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Terminated

Opthalmic Laser, product number 8065-5000-1

FDA Recall Z-0923-04 · Posted 2004-07-20

Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeHQF
Date Initiated2004-04-09
Date Terminated2004-08-30
Product Quantity62

Reason for Recall

Product may generate laser light flashback.

Firm Action

Additional in-service training materials have been prepared and will be delivered to users. Additional software upgrade will be made. Actvities will be complete in May 2004.

Root Cause

Other

Distribution Pattern

Nationwide and Sweden, Taiwan, Fiji Islands, Cyprus, Philippines.

Official Source

View FDA Recall →

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

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