Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

AMO PhacoFlex II Model SI40NB, Intraocular Lenses

FDA Recall Z-1036-03 · Posted 2003-07-22

Recalling FirmAllergan Medical Optics Inc
Recall StatusTerminated
Date Initiated2003-07-02
Date Terminated2004-04-30
Product Quantity98

Reason for Recall

Post operative complaints of cloudiness in the intraocular lenses.

Firm Action

Notification letters were sent July 2, 2003 to distributors and subdistributors. Customers were sent letters July 3 and 8, 2003.

Root Cause

Other

Distribution Pattern

Brazil only.

Official Source

View FDA Recall →

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

↑