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Terminated

Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.

FDA Recall Z-1445-2014 · Posted 2014-04-09

Recalling FirmAlcon LenSx, Inc.
Recall StatusTerminated
Product CodeOOE
Date Initiated2014-03-14
Date Terminated2014-10-16
Product Quantity75

Reason for Recall

Alcon LenSx received reports of unexpected downward motion of the gantry.

Firm Action

Alcon LenSx Inc advised customers of a Medical Device Correction being initiated for specific serial numbers of the LenSx Laser System for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation. Alcon sent customer notification letters via mail during the week of March 17, 2014. The letter titled "Medical Device Correction", advised customers of the correction and provided: the product's description with serial number(s), description of the potential condition, advise on action to be taken by the user, transmission of the notice, and a contact reference person. The letter also contained a section for customers to sign and return the page of the Notice to Alcon.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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