SIE AG recalls FEMTO LDV Z8 Femtosecond Surgical Lasers after customer complaints of cataract procedure complications. The recall addresses usability and performance improvements for safer ophthalmic surgery.
This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated a complication with a cataract procedure. An investigation completed by the manufacturer determined that although the complication was due to user error improvements could and should be made on our part to improve the usability and performance of our device.
SIE AG is recalling specific models of the FEMTO LDV Z8 Femtosecond Surgical Laser due to reported complications during cataract procedures. The issue relates to potential improvements in the device's usability and performance to prevent errors.
The hazard stems from reported complications during cataract procedures, which the manufacturer attributes to user error. The investigation found that improvements to the device's usability and performance could help prevent such errors.
Patients undergoing cataract surgery who use the recalled FEMTO LDV Z8 laser models are affected. Surgeons and medical staff using these specific serial numbers are most at risk.
Check for the following serial numbers: FLM4455, FLM2313, FLM4499, and other listed serial numbers in the recall notice. The device is used for ophthalmic surgeries including cataract procedures.
Identify if your device has one of the listed serial numbers: FLM4455, FLM2313, FLM4499, or other serial numbers provided in the recall notice.
The recall is based on customer complaints of complications during cataract procedures, with the manufacturer noting that improvements to the device's usability and performance could help prevent errors.
Check if your device has one of the listed serial numbers. If it does, contact SIE AG for further instructions.
The manufacturer states that the complications were due to user error, not inherent device failure. The recall focuses on improving usability and performance to reduce error risks.
We’ve drafted a message you can send SIE AG to request your refund or repair — edit it as you like.
Subject: Recall Z-1272-2018 — SIE AG SIE AG Hello, I own a SIE AG that is covered by recall Z-1272-2018 from SIE AG. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
