FEMTOLDV Z8Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640167750016), received between Nov 29, 2021 and Nov 29, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K150323); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem

  USER REPORTED THREE PATIENTS WITH OBSERVED POSTERIOR CAPSULE RUPTURES. ONE PATIENT ON (B)(6) 2021 (1176) AND TWO PATIENTS ON (B)(6) 2021 (1214 & 1216.) PATIENTS 1176 AND 1214 HAD BOTH ANTERIOR AND POSTERIOR VITRECTOMIES, AND ALL THREE REQUIRED A CHANGE TO SULCUS FIXATED 3 PIECE IOLS.

  Patient problems: Capsular Contracture

  MAUDE report 12882813 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150323. One submission often covers many models, so check the product and lot details in each record.

• Z-1272-2018 · Jan 21, 2018 · Terminated
  The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisio