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

STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.

FDA Recall Z-1964-2016 · Posted None

Recalling FirmStaar Surgical Co.
Recall StatusTerminated
Product CodeKYB
Date Initiated2016-05-02
Date Terminated2016-11-15
Product Quantity2,612 units

Reason for Recall

The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).

Firm Action

STAAR sent a Medical Device Recall Letter dated May 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STAAR Surgical is recalling the STAAR AQ Cartridge-FP because it may malfunction and may crack during loading or delivery of the IOL. Customers with questions are instructed to contact their STAAR customer service representative at (800) 352-7842.

Root Cause

Process control

Distribution Pattern

US

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K940593DISPOSABLE MICROSTAAR INJECTORStaar Sugical · 1994-09-19

Official Source

View FDA Recall →

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

↑