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Terminated

Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorporated, Rochester, NY For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery

FDA Recall Z-3089-2011 · Posted 2011-08-30

Recalling FirmBausch & Lomb Inc
Recall StatusTerminated
Product CodeHQC
Date Initiated2011-07-27
Date Terminated2013-06-21
Product Quantity2/6-unit cases

Reason for Recall

The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction

Firm Action

Bausch & Lomb Inc. notified all affected customers by direct telephone contact on July 27, 2011 and a follow-up FAX or e-mail dated July 27, 2011 The letter included; affected product, problem, and requests customers return the product. An acknowledgement form was included to complete and return with the product. For question on this recall contact Bausch & Lomb at (949) 521-7895.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082473BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEMBausch & Lomb, Inc. · 2009-01-05

Official Source

View FDA Recall →

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

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