Abbott Medical Optics, Inc.

Complete recall history across all FDA and CPSC categories — 9 total recalls

Abbott Medical Optics, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (9)

FDA medical device enforcement actions by Abbott Medical Optics, Inc.

Date Product Reason Class
Feb 20, 2015 OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and C... Device may experience loss of suction during treatment resulting in scoring t... Class II
Sep 16, 2013 STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Produ... This corrective action will address an identified failure of the lamp and ill... Class II
Sep 16, 2013 STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product... This corrective action will address an identified failure of the lamp and ill... Class II
Sep 16, 2013 STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-24... This corrective action will address an identified failure of the lamp and ill... Class II
Sep 16, 2013 STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalo... This corrective action will address an identified failure of the lamp and ill... Class II
May 28, 2013 STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA... Under specific conditions, there is an unlikely potential to result in inadve... Class II
May 28, 2013 STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC ... Under specific conditions, there is an unlikely potential to result in inadve... Class II
May 28, 2013 STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO M... Under specific conditions, there is an unlikely potential to result in inadve... Class II
May 23, 2013 Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300.... Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Devi... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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