Alcon recalls 25GA Valved Entry System (model 8065751658) due to sharpness complaints. Affected units may cause injury during ophthalmic procedures.
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
Alcon is recalling a specific ophthalmic surgical device because reports of sharpness issues have increased. This could lead to injury during eye surgery procedures if the device is used without proper care.
The device has been reported to be sharper than expected, which could cause injury to the eye or surrounding tissues during surgical procedures. This sharpness issue is related to specific model numbers and lot batches.
Ophthalmic surgeons and medical professionals who use the 25GA Valved Entry System for eye surgeries are most at risk. Patients undergoing procedures with this device may also be affected.
Check for the model number 8065751658 on the device packaging or label. The affected units were sold with lot numbers 16C4MR, 16K84T, or 16FXTD.
Verify the model number on the device packaging or label to confirm if it matches 8065751658.
Reach out to Alcon Research LLC for further guidance on handling the recalled device.
The device has been reported to be sharper than expected, which could cause injury during eye surgery procedures. However, the recall does not specify that the device is immediately dangerous in normal use.
Check for the model number 8065751658 on the device packaging or label. Affected units were sold with lot numbers 16C4MR, 16K84T, or 16FXTD.
Contact Alcon Research LLC for guidance on handling the recalled device. The recall does not specify a specific action like discarding or returning the device.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-2646-2024 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-2646-2024 from Alcon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
