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Terminated

Sunsoft Multiples Toric, methafilcon A, clear contact lens.

FDA Recall Z-0348-05 · Posted 2004-12-23

Recalling FirmOcular Sciences, Inc.
Recall StatusTerminated
Product CodeLPL
Date Initiated2004-12-09
Date Terminated2005-03-31
Product Quantity46 lenses

Reason for Recall

Vials containing the lenses are possibly contaminated with residual hydrogen peroxide.

Firm Action

All consignees were notified by courier on 12/09/2004.

Root Cause

Other

Distribution Pattern

AR, AZ, CA, DC, GA, MI, MO, MS, NJ, NM, OR, PA, TN, TX, WI. No government, military or foreign distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964696SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENSSunsoft Corp. · 1997-02-20

Official Source

View FDA Recall →

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

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