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

C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following phacoemulsification

FDA Recall Z-3282-2018 · Posted None

Recalling FirmRayner Intraocular Lenses Limited
Recall StatusTerminated
Product CodeHQL
Date Initiated2018-08-09
Date Terminated2020-11-24
Product Quantity49

Reason for Recall

Firm become aware of reports of post-operative refractive errors following implantation of lenses.

Firm Action

On August 31 the firm sent letters to all customers (health care facilities) that have received lenses in this batch and instructed to quarantine any remaining unused lenses from the C-flex 570C +19.0D batch 017100825. Replacement, reimbursement or substitution is offered (as appropriate).

Root Cause

Error in labeling

Distribution Pattern

US in the states of MO

Official Source

View FDA Recall →

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

↑