Alcon Research LLC is recalling approximately 303,257 Constellation Vision System surgical procedure packs because some units were damaged during the manufacturing process. The damage specifically affects the lidding of the packs, which could compromise the sterile barrier of the instruments inside. This recall includes the Vitrectomy Procedure Pak, the Combined Procedure Pak, and various Custom Paks designed for ophthalmic surgeries. Consumers should stop using the affected products immediately and contact the manufacturer to arrange for their return or replacement.
Risk
Damaged packaging lidding poses a significant risk of compromising the sterility of the surgical instruments. Using non-sterile instruments during eye surgery can lead to serious patient infections or other complications.
What You Should Do
This recall affects Alcon Laboratories Constellation Vision System Vitrectomy Procedure Paks, Combined Procedure Paks, and various Custom Paks used for ophthalmic surgeries.
Check your inventory for the affected catalog numbers and lot codes. This recall covers a high volume of identifiers, including catalog numbers 8065000093, 8065000095, 8065000096, 8065752435, 8065752436, 8065752437, 8065752438, 8065752439, 8065752449, 8065752450, 8065752451, 8065753106, 8065753109, 8065830077, 8065751058, 8065751077, 8065751155, 8065751613, 8065751617, 8065751715, 8065751765, 8065751767, 8065751865, and 8065752448. See the Affected Products section below for the full list of affected codes.
Stop using the recalled products immediately to avoid the risk of using non-sterile surgical equipment.
Contact the manufacturer or your distributor to arrange for the return, replacement, or correction of the affected paks.
Call the FDA's medical device recall line for more information at 1-888-463-6332 (1-888-INFO-FDA).
Your Remedy Options
📋Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
Affected Products
Product: Constellation Vision System Vitrectomy Procedure Pak
Variants: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU, 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU, 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU, TOTAL PLUS, 23G, 10K VALVE STD, TOTAL PLUS, 23GA, 10K VALVE WD, TOTAL PLUS, 25+, 10K VALVE STD, TOTAL PLUS, 25+, 10K VALVE WD, TOTAL PLUS, 27+, 10K VALVE STD, 23G CMB PAK 10K CPM, V, WA 0.9, 25+ CMB PAK 10K CPM, V, STD 0.9, 25+ CMB PAK 10K CPM, V, WA 0.9, 25+TTLPL VPK 20000CPM BEV VAL, 27+TTLPL VPK 20000CPM BEV VL, 25+ TTL PLUS VPAK 20000CPM BWV
Model / REF:
8065000093
8065000095
8065000096
8065752435
8065752436
8065752437
8065752438
8065752439
8065752449
8065752450
8065752451
8065753106
8065753109
8065830077
Lot Numbers (296):
177FE4
1782JM
178DEX
178TCV
179EP4
179EP3
179U0P
17AVMM
17AVMN
17AVML
17AVMP
1782JU
1782JT
178DF2
178TCY
178TD0
1792YF
1792YE
179U0R
17A4XT
17A4XU
17AFXT
17AVMT
17AVMU
17AVMV
17AVMW
17AVMX
17CNVC
1782JV
178DF4
17A4XV
1754N7
1754NC
175M43
1762KH
176CCJ
176CCK
176WU8
176WU9
17769X
1782HM
1782HN
178T9K
179EEV
179TY3
179TY4
17A4WX
17C7FM
17C7FL
1762KJ
UDI:
380650000934
380650000958
380650000965
380657524358
380657524365
380657524372
380657524389
380657524396
380657524495
380657524501
380657524518
380657531066
380657531097
380658300777
Surgical procedure pack to interface with Alcon Constellation Surgical console.
Product: Constellation Vision System Combined Procedure Pak
Variants: TOTAL PLUS PAK, 23G, 5.0 CPM, STDRFID, COMBINED PAK, 23G, 5.0 CPM, 0.9STD, RFID, ANTERIOR PAK, 0.9, W/0 PROBE/IL-LUMINATIO, 23G POST TPP VAL STD 7500, TOTAL PLUS, 25+ 7.5CPM VALVE, TPP CONST 25+ SHORT 7500CPM, 23G CMB PAK 7.5CPM V STD 0.9, 25+ CMB PAK 7.5CPM, V, STD 0.9, CNST ANTERIOR PK, 0.9MM, W/O PROBE, BNB, 23G CMB PAK 10K CPM, V, STD 0.9
Model / REF:
8065751058
8065751077
8065751155
8065751613
8065751617
8065751715
8065751765
8065751767
8065751865
8065752448
Lot Numbers (112):
1762K1
176WTW
177TVD
179EE9
179EEA
178D4X
1782FY
1782H0
1782H1
178D4Y
178D51
178D52
178RYU
178RYV
178RYW
178RYX
1792YK
179EED
179EEE
179EEF
179EEH
179TXM
179TXN
179TXP
17AVLU
17AVLV
17C7H2
17CNRM
17CNRN
17CNRP
17CNRR
17CNRT
1754MX
1754T1
175M41
1762K7
176CC8
176CC9
176CCA
176WU5
17769P
1782HA
1782HC
178D54
179EEJ
179TXU
17AFT8
17AVLW
17C7FX
17C7FY
UDI:
380657510580
380657510771
380657511556
380657516131
380657516179
380657517152
380657517657
380657517671
380657518654
380657524488
Surgical procedure pack to interface with Alcon Constellation Surgical console.
Product: Custom Pak
Variants: J-CAT PAK - CVS, AUS-CATARACT, 25G VIT 25G, VITRECTOMY 25G, CATARACT, 23G CONSTELLATION, AUS-25GA VIT RET, AUS-23GA 10K COMBINED VR PAK, 23GA CVS RETINA TPP V, 23G VIT CONSTELLATION, 25+G 20K VIT CONSTELLATION, CDN-VIT 25G 7.5K, J-COMB PAK - 25G 20K CVS, CDN-CVS VIT 23G VE 7.5K, CDN-CVS VIT 25G+ VE 10K, CDN-CVS VIT 10K 25G+, CDN-CVS VIT 25G+ 20K BV, CDN-CVS VIT 23G 10K, CDN-CVS VIT 23G VE, CDN-CVS VIT 25G+ 10K, CDN-CVS VIT 25G+ BWV 20K, CDN-CVS COMBO 23G 10K, 25G PLUS VITRECTOMY, CDN-UHN 23G COMBO VE 10K, CDN-UHN 23G VIT VE 10K, CDN-CVS 23G COMBO VE 10K, CDN-CVS 23G VIT VE 10K, CDN-COMBO-VIT 25G 7.5K, 23G VIT PACK, 27G VIT PACK, 25G+ VIT PACK, CDN-CVS VIT 25G+ 10K WA, MEX-VIT PAK (CVS 23GA), MEX-VIT PAK (CVS 25+), CDN-CVS COMBO 23G VE, J-VIT PAK - 25G 20K CVS, 23G VITRECTOMY, CDN-CVS COMBO 25G+ 10K, 25G VALVED, 23G VALVED, J-CAT-CVS2.75MM, J-COMB PAK - 25G 10K CVS, AUS-WPH-CONSTELLATION VR 25G, J-CVS PEA PAK, CDN-CVS VIT 25G+ WV 7.5K, CDN-CVS 25G+ VIT VE 10K, 25G CONSTELLATION, J-VIT PAK - 25G 10K CVS, AUS-VITRECTOMY 23GA, AUS-VITRECTOMY 25+GA, CDN-CVS VIT 25G VE 10K, CDN-CVS COMBO 25G VE 10K, CDN-DEVENYI COMBO PK 10K, AUS-CONSTELLATION VR PAK, J-CAT ALL-IN ONE PAK - CVS, MEX-VIT PAK (CVS 27+), MEX-VIT COMB PAK (CVS 27+), MEX-VIT COMB PAK (CVS 25+), J-CVS CAT PAK (W_IA, W_O SLIT), J-CAT ALL-IN PAK - CVS, CDN-POST VIT 23G V 7.5K, CDN-COMBO RETINAL PACK COMBO, VIT FRANKLIN 27G, VIT FRANKLIN 25G, CDN-RETINAL VIT PACK 20K, CDN-CVS VIT 25G+ BV 20K, AUS-WPH-CONSTELLATION VR 23G, CDN-CVS 23G VIT 10K, J-VIT PAK - 27G 20K CVS, J-COMB 25G20K (W_IA, W_O SLIT), NZ-MERCY-VR-PAK VITRECTOMY, NZ -SSURGERY VITRECTOMY, NZ-TP 25+G VAL VIT PHACO COMB, NZ-TP 25+G VAL VIT, CDN-NRGH RETINA PAK, CDN-CVS VIT 25G+ 20K, CDN-CVS COMBO 25G+ 20K, CDN-CVS VIT 25G VE 20K, CDN-CVS COMBO 25G VE 20K, NZ-SSURGERY-CONSTELL CATARACT, CDN-25G VITRECTOMY, AUS-CONSTELLATION VR 25G 20K, CDN-VIT HOUSE PACK E (25G 20K), CDN-CVS 25G+ VIT VE 20K, CDN-CVS ANTERIOR 2.75, P-VITRECTOMIA, GB-CONSTELLATION PHACO, D-KAT PAK, ZA-DR SEGOATI PHACO PAK, F-CH PERPIGNAN CONST, I-CPKB-VITREO 23GA 10K, F-GSH VITREC CONSTEL 23G 7.5, F-CPKB-CL MONTICELLI CONST 25G+ V, F-CH VILLEFRANCHE CONSTELLATIO, E-PAK PARA VIT 23G CONST, E-PAK VITREO CONST 23G 10K, F-ST ROCH CONSTEL 23G V 10K, SF-TAKAOSAPAKKAU, F-HCL CONSTEL MIC 2.2, PL-LUBLIN SPSK1 CONST 23G, E-PAK VITREO CONST 25G 20K, PL-WROCLAW WSS CONST 23G, F-COURLANCY REIMS VITRE 25G+ V, PL-W-WA SPKSO CONST 25G+, PL-BIELAWA OKULISTYKA CONST 25G, F-ST JEAN DE DIEU CONS 25G+ 10, E-PAK CONSTELLATION 25G 20K, GB-POSTERIOR 25G 10K, P-VIT CONSTELLATION 23G V, F-SANTE ATL CONSTEL PHACO 2.2, F-SANTE ATL VITREC 25G+ 20K, DK-25G VIT PAK GADSTRUP 20K, GB-23G POST CONSTELLATION 7.5K VR PAK, D-CPAK CVS BREMEN MITTE, NL-DUO PAK 25G VITR. PAK 10K, GB-CONS PHACO PAK, E-PAK PARA COSNTELLATION 23G, F-PACK CONSTEL 25G+ VALVE, E-PAK VITREO CONSTELLATION 25G 20K, E-PAK PARA CONST.COMBI 25G, PL-LODZ WAM CONSTELL FACO, GB-CONSTELLATION 23G 7.5K VR PAK, PL-GDANSK UCK CONST 25G, F-CH ANNECY GENEVOIS CONST 2.2, PL-KOSTRZYN SZPITAL CONST 23G, DK-ODENSE 25+G VIT CONSTELLATION + SAUT, E-PAK PARA FACO CONSTELLATION, B-DR CLAES VIT-10CPM PAK 23G, F-CL C. BERNARD CONSTEL 2.2, PL-W-WA MAVIT CONST 25G, I-FACO CONST 2.2, E-CPKB PARA VITREO 25G, DK-NASTVED 25 G CONSTELLATION VIT PAKKE, D-23G VIT CPAK UNI FREIBURG, NL-CATHARINA VITR PAK 25G CVS, NL-CATHARINA COMB. 25G PAK CVS, F-CL PARC CONST CATARACTE, F-DR HUBERT CONSTEL 25G 10K, F-ST ANDRE CONSTEL PHACO 2.2, F-CH BOULOGNE CONSTEL, E-PAK VITREO CONSTELLATION 23G 10K, PL-KOSZALIN SZP.WOJ CONST 25G, PL-LOMZA SZP.WOJ. CONST 23G, I-CPKB FACO MINITIP GENOVA ASL, F-CH MANTES CATARACTE CONST, CZ-CONSTELL ANTERIOR OBECNY, PL-ZGORZELEC WSSPZOZ CONST 25G, PL-LUBLIN SPSK1 CONST 25G COMB, F-CL C BERNARD CONS 25G+V 10K, E-PAK VITREO CONST 25G, PL-KROSNO/WSP CONST 25G, PL-OLSZTYN MSZ 25G COMB+, S-LINKOPING VITREKTOMI PAK 25G, PL-LUBIN MCZ CONST 23G, GB - 25G COMB PAK 20K, PL-BYTOM/SS NR.1 CONST 23G ILM, E-PAK CONST. 23G 7500, GB-PHACO 2.75MM PAK, F-CL CARDELLA CONSTELL MIC 2,2, P-VITRECTOMIA COMBINADA, PL-KRAKOW SU CONST. 25G COMB, PL-KRAKOW SU CONST. 25G, I-VITREO 23GA 10K, E-PAK VITREO 23G 10K, F-SANTE ATL VITREC 27G+ 20K, P-VITRECTOMIA 27G 10K, PL-POZNAN SKPP CONST 23G, F-CHP ST GREG VITRECT SIMPLE 25G 10K, B-VIT PAK 25G 10K UZB, E-PAK COMBI CONST 25G 20K, SF-OYS VITREKTOMIA 25+G, SF-OYS VITREKTOMIA 23+G, SF-OYS VITREKTOMIA 27+G, F-RETINE COMB CONST 25G 20K, I-CPKB FACO GIOVANNI ROTONDO, PL-GLIWICE/SZ.MIEJSKI CONSTEL FACO, F-JOUVENET CONST 2.2, GB-25G COMBI 20K PAK, D-KAT PAK CHARLOTTENKLINIK CON, D-KAT PAK CHARLOTTENKLINIK COMP. CONST, PL-SLUPSK WSS CONST 25G, I-VITREO 25GA 10K, I-FACO CONST, PL-BIELSKO-BIALA WSS CONS 25G COMB, PL-OPOLE/USK CONST 23G, PL-OPOLE/USK CONST 25G+, I-VITREO 25GA STD, I-VITREO 25GA COMBO 20K, E-PAK PARA VITREO 25G 20K, F-STE MARIE VITRECT 23G 10CPM, F-STE MARIE VITRECT 25G+ 10CPM, I-FACO2, GB-CONSTELLATION PHACO PAK, I-CPKB CONSTEL 23GA CDC CANDEL, PL-WROCLAW/4.WSK CONST 23G, NL-RETINA OC COMB.PAK 20K 25G, NL-RETINA OC VITR.PAK 20K 25G, PL-BIELAWA OKULISTYKA CONSTEL FACO, I-VITREO 25GA 20K, PL-KATOWICE MAVIT CONST 25G, PL-GDANSK UCK CONS 25G NOZYCZKI, E-PAK PARA FACO, I-FACO CONSTELLATION, E-PAK CONST 25+ 10000, PL-W-WA/ORLOWSKIEGO 25G COMB, I-VITREO 25GA LOTTO 5 20K, F-GEOFFROY CONSTEL 2.2 EMB IA, I-VITREO 25GA VALV. COMBO 20K, PL-POZNAN SZP.KLINI. CONST 25G, I-VITREO 23GA DISTACCO, GB-25G VR 20K PAK, AE-MEDICLINIC KHALIFA, E-PAK FACO CONSTELLATION, LT-25G VITRECTOMY PAK SANTAR., NL-CWZ PHACO PAK CVS OD-R, NL-CWZ PHACO PAK CVS OS-L, I-FACO, I-CPK S.BIAGIO 2.4, F-PERGOLA CONSTEL 23G, GB-CONSTELLATION 25G 10K POSTERIOR, E-PAK I SOFIA CONST 25G 10K, E-PAK CONSTELLATION 23G, E-PAK CONSTELLATION 25G, AE-VIT-RET 23G PROCEDURE PAK, I-VITRECTOMIA 25G COMBO 20K, D-KAT-SET BREYER- KAYMAK CONS, E-PAK VITREO 25G 20K, F-PACK CONSTEL VITRECT 25G, PL-BYDGOSZCZ SU NR1 CONSTEL FACO, I-VITREO 25GA CONST, IRL-27G POSTERIOR 20K VITRECTOMY, E-PAK SANTIAGO VIT 25G 20K, E-PAK VITREO CONST 25G 20K RECTA, E-PAK VIT CONST MERIDA 25G 10K, E-PAK SMS VITREO CONST 25G 20K, E-PAK SMS COMB CONST 25G 20K, PL-BIELSKO-BIALA WSS CONST 25G POD, I-VITREO 25GA COMBO 20K + PUNTA, F-CH LENS VITRECT 23G, F-CH LENS VITRECT 25G, DK-CONSTELLATION 25+ GAUGE COMBI, PL-KOSZALIN/SZP.WOJ. CONST FACO, B-DR PION CONST PAK, I-VITREO23GA VALV, PL-ZIELONA G-SU CONST 25G, ZA-VIT BASIC PAK, GB-PHACO ENHANCED WITH TIP, I-CONSTELLATION, F-CL ERMITAGE MELUN VITREC 25G 10K, F-CL ERMITAGE MELUN CONST PHACO 2.2, F-CMC JOCKEYS VITREC 25G 20K, GB-23G VR 7.5K PAK, S-SWEDEN VITRET STD 20K PAK, F-PLC F.COMTE CONST 25G+ 10K, NL-VITRET CPK DRECHTSTEDEN, F-CHP EUROPE VITRECT 25G+ 20K, I-VITREO 25GA - LOTTO 117, E-PAK VITREO CONST 23G 10K RECTA, F-CL EPERNAY CONSTEL PHACO 2.2, F-CH CANNES VITRECTOMIE 25G 10K, E-PAK VIT CONST 25G 20K, E-PAK VIT CONST 27 20K, GB-CONSTELLATION 25G POST 10K PAK, CZ-CONSTELL 25GA PEEL 20T HYP, I-VITREO 25GA CONSTELLATION, SF-TAYS VITREKTOMIA, SF-TAYS COMBINED, GR-ALCON VIT CPK 20K CPM W_O TIPS, I-LOTTO 39.1 CONSTELLATION, I-LOTTO 39.6 VITREO 25G, I-VITREO 25G COMBO 20K, I-VITREO 27G 20K, SF-KYS VITRECTOMY PAK 20K, PL-ZIELONA G. SU CONST 23G ILM, F-CH ST BRIEUC CONST PHACO LOT 23 1, D-VIT PAK 25G TOTAL PLUS PAK 10K MARZAHN, GB-25G CONSTELL COMBI 20K, I- FACO LOTTO A, PL-STARACHOWICE PZOZ CONST 25G, I-VITREO CONST.25GA COMBO 20K, I-VITREO CONST.23GA 10K, I-VITREO CONST.25GA 20K, NL-FYEO VITRECTOMY PAK 25G 20K, D-VIT PAK ST. GERTRAUDEN 25G 20K, D-VIT PAK 25G-20K- PP, NL-COMB ABLATIOPAK 20K 25G, NL-VITRECTOMIE ABLATIOPAK 20K 25G, I-VITREO 23 GA 10K NO PINZA, I-CPK GEMELLI 25 GA 20K NO PINZA, F-CL JUGE VITREC 25G 10K, F-CLINIQUE AVICENNE LE PORT CONST 25G 20, PL-LODZ WAM CONST 25G COMB, PL-BYDGOSZCZ SU NR1 CONST 25G COMB, F-H EUROPEEN ROSERAIE CONST PH 2.2
Model / REF (383):
0094-77
10366-13
10924-15
11201-11
11220-27
1137-65
12568-09
12641-14
12852-16
13110-11
13501-08
13502-10
13591-13
13592-15
14217-12
14283-12
14503-07
14512-10
14532-07
14540-08
14597-07
14603-15
14671-09
14672-11
14873-06
14955-09
14956-08
15006-07
15108-09
15223-13
15294-13
15318-06
15318-07
15324-07
15421-12
15455-10
15456-05
15464-05
15465-05
15480-13
15491-06
15492-03
15493-06
15525-04
15552-05
15553-05
15722-08
15723-08
15853-05
15877-07
Lot Numbers (810):
17C3H9
17CY90
176JX0
17A18R
17A1AW
176NYN
1772HN
1772L9
177URH
179TKU
17CF2K
17AMJJ
17AMMW
17CLCN
179Y3T
17A46H
17CXY9
178PTE
17CK02
178KD6
179N1E
17AKR3
177DMP
178423
178N3H
178UD9
17AHCE
17AX1V
17CCAH
17703Y
178VKT
176899
17ACTU
177EJK
178U4X
178JD0
17CVV7
17D2F2
1783PC
177UN3
178DW0
178DYH
178PPU
179N1V
179UEA
179V5H
17AVV3
17CH2A
1797UX
179X2P
UDI (383):
380655137888
380655161951
380651690714
380655184899
380655178492
380653436938
380653414561
380655181935
380655158425
380655177549
380653441505
380655155912
380655164570
380655164433
380653432602
380655123829
380655141953
380655191378
380655187586
380655116074
380655160046
380651696402
380651674882
380651696419
380655156094
380655183243
380655181980
380655178928
380651696464
380655114452
380651697027
380655191385
380655199497
380655138113
380653441703
380655196595
380655181997
380651638211
380651638228
380651697386
380655191279
380655191286
380655191293
380655114674
380653442373
380653442540
380651693470
380651693562
380655138137
380655141915
Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries.
Additional Information
Agency: Food and Drug Administration (FDA)
Event ID: 96832
Status: Active
Manufacturer: Alcon Research LLC
Sold By: Authorized distributors; Medical supply channels
Manufactured In: United States
Units Affected: 3 products (198205; 89495; 15557 kits)
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia
Were You Affected by This Recall?
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.
