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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Alcon Research LLC: Ophthalmic Knives Recalled for Reduced Sharpness

Agency Publication Date: May 30, 2024
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Summary

Alcon Research LLC has recalled 481,751 ophthalmic knives, including ClearCut Sideport and A-OK V-Lance models, because they may not be sharp enough for their intended surgical use. The company has received an increased number of complaints regarding the sharpness of these surgical instruments. While sterile stand-alone knives have been placed on hold, those included in Alcon Custom Paks are still being distributed to prevent surgical cancellations and market shortages.

Risk

If a surgical knife is not sharp enough, it may fail to make a clean incision or require additional force, potentially leading to surgical complications or tissue damage during delicate eye procedures.

What You Should Do

  1. Identify if you have the affected knives by checking for the following catalog numbers: 8065912001 (20 Gauge V-Lance), 8065921541 (ClearCut 1.2mm Angled), 8065771540 (ClearCut S 1.0mm), or 8065771541 (ClearCut S 1.2mm).
  2. Verify the specific lot numbers on your packaging. Affected lots include 15W9CJ, 161A10, 161A2M, 15W7XT, 15W7Y8, 15W7Y9, 1668D7, 167PRA, 168NME, and many others listed in the product details.
  3. If you possess stand-alone knives from the affected lots, follow the instructions provided in the notification letter from Alcon to place the products on hold and prevent their use.
  4. If you have Alcon Custom Paks containing these knives, you may continue to use them as directed by the manufacturer to avoid canceling necessary surgeries, but be aware of the reported sharpness issues.
  5. Contact your healthcare provider or Alcon Research LLC directly for further instructions and information regarding potential replacements or refunds.
  6. For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Product hold and usage monitoring

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: 20 Gauge V-Lance Knife
Model / REF:
8065912001
UPC Codes:
00380659120015
Lot Numbers:
15W9CJ
161A10
161A2M
163701
164WWX
16D4VU
Product: ClearCut Sideport Knife Dual Bevel 1.2mm Angled
Model / REF:
8065921541
UPC Codes:
00380659215414
Lot Numbers (78):
15W7XT
15W7Y8
15W7Y9
15W9E6
15W9E8
15X5JJ
15X56A
15X56C
15X5KV
15X5KX
1618UH
1618UJ
161A1K
1618V4
1618V5
161A21
161A22
162WY5
162WY6
162WYL
162WYN
1636Y8
1636Y9
1636YV
164RXL
164RY8
164RYA
164WV3
164WW9
164WWC
1668MR
1668MT
1668NH
1668NJ
1668NK
166E89
166E90
166E91
167PVK
167R34
167PW7
167PW8
167PW9
167R3K
167R3L
168TE8
168UEX
168TEN
168UFJ
168UFL
Product: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel
Model / REF:
8065771540
UPC Codes:
00380657715404
Lot Numbers:
1668D7
167PRA
167PTK
168NMF
169KL4
169KTP
16ALPE
16ALTU
16AV18
16DDPR
16DDRU
Product: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel
Model / REF:
8065771541
UPC Codes:
00380657715411
Lot Numbers:
168NME
168NND
16AV17

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94501
Status: Active
Manufacturer: Alcon Research LLC
Sold By: Alcon Research LLC; Aspex Facility
Manufactured In: United States
Units Affected: 4 products (29,190 units; 427,764 units; 19,867 units; 4,930 units)
Distributed To: Nationwide

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.

Find an Attorney

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.

Sources: FDA iRES ยท Raw API Response

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.