Z-0348-05

Sunsoft Multiples Toric, methafilcon A, clear contact lens

Name: Z-0348-05 Sunsoft Multiples Toric, methafilcon A, clear contact lens
Creator: Ocular Sciences, Inc.
Published: 2004-12-09
License: https://open.fda.gov/license/

Ocular Sciences / initiated 2004-12-09 / Terminated

FDA source

Ocular Sciences, Inc. began a recall of Sunsoft Multiples Toric, methafilcon A, clear contact lens on 2004-12-09. The reason FDA records is "Vials containing the lenses are possibly contaminated with residual hydrogen peroxide". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0348-05
Status: Terminated
Initiated: 2004-12-09
Posted: 2004-12-23
Terminated: 2005-03-31
Recalling firm: Ocular Sciences
Product: Sunsoft Multiples Toric, methafilcon A, clear contact lens.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Vials containing the lenses are possibly contaminated with residual hydrogen peroxide.
FDA root cause: Other
Action: All consignees were notified by courier on 12/09/2004.
Quantity in commerce: 46 lenses
Distribution: AR, AZ, CA, DC, GA, MI, MO, MS, NJ, NM, OR, PA, TN, TX, WI. No government, military or foreign distribution.
Product codes and lots: Lot Number 12981729

Product code LPL

K964696Class IISunsoft (Methafilcon a) Soft (Hydrophilic) Daily Wear Contact LensSunsoft Corp. / cleared 1997-02-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)