Z-0125-2010

ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and...

Name: Z-0125-2010 ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and...
Creator: CooperVision Inc.
Published: 2009-08-28
License: https://open.fda.gov/license/

CooperVision, Inc. / initiated 2009-08-28 / Terminated / root cause: packaging

FDA source

CooperVision Inc. began a recall of ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK... on 2009-08-28. The reason FDA records is "Thirty-eight lots of Ocufilcon D 55% 1-Day Toric Contact Lens with a modified packaging solution sold under the brand name ClearSight 1-Day Toric were inadvertently shipped into the US market prior to complete...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0125-2010
Status: Terminated
Initiated: 2009-08-28
Posted: 2009-11-09
Terminated: 2012-06-12
Recalling firm: CooperVision, Inc.
Product: ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK, and Scottsville, NY 14546 USA --- Each lens is supplied sterile in a blister containing buffered saline solution. The blister is labeled with the base curve, diameter, dioptric power, manufacturing lot number, and expiration date of the lens. ClearSight contact lenses are made from a material containing 55% water and 45% ocufilcon D, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling. When placed on the cornea in its hydrated state, the ClearSight" (ocufilcon D) Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
Product code: MVN Lens, Contact, (Disposable)
Reason for recall: Thirty-eight lots of Ocufilcon D 55% 1-Day Toric Contact Lens with a modified packaging solution sold under the brand name ClearSight 1-Day Toric were inadvertently shipped into the US market prior to complete evaluation of the 510(k) by the FDA.
Root cause tag: packaging
FDA root cause: Other
Action: Urgent: Medical Device Recall - Contact Lens letters, dated 8/28/09, Response Forms, along with reorder forms and postage paid return labels were sent to the consignees via first class mail with instructions for returning the affected product. Customers are to examine their inventory and customer records to determine if they have any of the affected product. The affected products are to be returned and CooperVision will reimburse for all postage associated with the return and replace the lenses free of charge. Questions should be directed to Bonnie Tsymbal at (800) 341-2020 ext. 3210.
Quantity in commerce: 1440 cartons
Distribution: Nationwide Distribution
Product codes and lots: Lot numbers: 446450034703 (Power -0075075090), 446850021203 (Power -0075125090), 446450034904 (Power -0100075090), 446450031005 (Power -0125075090), 446450030905 (Power -0125075090), 46450031105 (Power -0125075090), 446850024806 (Power -0150125090), 447050023406 (Power -0150125180), 447050022408 (Power -0200125180), 446450031509 (Power -0225075090), 447050024509 (Power -0225125180), 446650019310 (Power -0250075180), 446650020510 (Power -0250075180), 447050022510 (Power -0250125180), 446650019411(Power -0275075180), 446650020611(Power -0275075180), 446650019512 (Power -0300075180), 447050022812(Power -0300125180), 447050022912 (Power -0300125180), 447050022712 (Power -0300125180), 446650019914 (Power -0350075180), 446650021314 (Power -0375075180), 446650019616 (Power -0400075180), 446650020816 (Power -0400075180), 447050023016 (Power -0400125180), 446650020017(Power -0425075180), 447050023117 (Power -0425125180), 447050023218(Power -0450125180), 447050024118 (Power -0450125180), 447050024718 (Power -0450125180), 446650020119 (Power -0475075180), 447050023319(Power -0475125180), 447050024219 (Power -0475125180), 447050021022(Power -0550125180), 447050021122 (Power -0550125180), 447050023522(Power -0550125180), 447050023624 (Power -0600125180), and 446650016926(Power -0650075180).

Product code MVN

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)