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Terminated

Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.

FDA Recall Z-1670-2013 · Posted 2013-07-09

Recalling FirmAbbott Medical Optics, Inc.
Recall StatusTerminated
Product CodeHQC
Date Initiated2013-05-23
Date Terminated2014-10-06
Product Quantity534 systems

Reason for Recall

Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Advisory Notice to all customers who use the AMO Sovereign Compact Phacoemulsification System, Version 5.3, because it has the potential to lose the vacuum tone mode during surgery.

Firm Action

AMO issued an "Urgent Notice of Medical Device Correction and Advisory Notice" on May 23, 2013 via email, to all customers with a Sovereign Compact Phacoemulsification System v 5.3 to inform them of the issue and provide them with actions to take in the event of sound loss during use of the Sovereign Compact Phacoemulsification System, v 5.3.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111446SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEMAbbott Medical Optics, Inc. · 2011-12-21

Official Source

View FDA Recall →

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

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