Z-1313-04

Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact lenses, 38% water, 62%...

Name: Z-1313-04 Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact lenses, 38% water, 62%...
Creator: The Contact Lens Store, Inc.
Published: 2004-06-07
License: https://open.fda.gov/license/

The Contact Lens Store, Inc. / initiated 2004-06-07 / Terminated / root cause: labeling and UDI

FDA source

The Contact Lens Store, Inc. began a recall of Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact lenses, 38% water, 62% polymacon, immersed in 0.9% buffered saline solution USP... on 2004-06-07. The reason FDA records is "The contact lenses were repacked in vials that were not sterile as indicated on the vial labeling". 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-1313-04
Status: Terminated
Initiated: 2004-06-07
Posted: 2004-08-05
Terminated: 2004-09-16
Recalling firm: The Contact Lens Store, Inc.
Product: Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact lenses, 38% water, 62% polymacon, immersed in 0.9% buffered saline solution USP, Manufactured by Soft Lens Technology, Lot BB43 Expiration Date 08/06, Cosmetic Use Daily Wear ***Decorative Theatrical Contact Lenses, packed in vials labeled sterile. Types include: Zombie, Banshee, Green Leaf, Green Reptile, White Cat, Manson, Green Rave, Moon & Stars, Blackwolf, Fire, Black Out, Pink Rave, Spiral, Flower Power, Starfire, Yellow Cat Eye, Computer Chip, Target, Red Cat, Blue Rave, Smiley, White Snowflake and Red Vampire..
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: The contact lenses were repacked in vials that were not sterile as indicated on the vial labeling.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were first contacted by telephone with a f/u letter sent 6/7/2004
Quantity in commerce: 618 vials
Distribution: MA, TX, WA.
Product codes and lots: Unknown. The firm failed to establish a lot numbering system for the theatrical contact lenses. The majority of the vials in stock at the firm have lot number BB43.

Product code LPL

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)