Z-1093-04

SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens

Name: Z-1093-04 SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens
Creator: Bausch & Lomb Surgical, Inc.
Published: 2004-02-27
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2004-02-27 / Terminated / root cause: labeling and UDI

FDA source

Bausch & Lomb Surgical, Inc. began a recall of SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens on 2004-02-27. The reason FDA records is "Lens may be labeled with incorrect diopter size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1093-04
Status: Terminated
Initiated: 2004-02-27
Posted: 2004-07-20
Terminated: 2012-05-03
Recalling firm: Bausch & Lomb Incorporated
Product: SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens.
Product code: HQL Intraocular Lens
Reason for recall: Lens may be labeled with incorrect diopter size.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm telephoned direct medical facility consginees on 2/27/2004 instructing to determine the disposition of the lenses and to return unimplanted ones. Follow-up phone calls were made in March 2004 for unresolved consignees.
Quantity in commerce: 36
Distribution: Nationwide & puerto rico. FL, MA, CA, CT, MI, NY, IN, ID, GA, PA, IL, CO, TN, NC, PR, TX, ME and OH.
Product codes and lots: 8XRJ

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)