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

FDA device recall Z-0125-2010 · posted 2009-11-09 · Terminated

Recall details

Recalling firm

CooperVision Inc.

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

MVN

Quantity affected

1440 cartons

Distribution

Nationwide Distribution

Date initiated

2009-08-28

Date posted

2009-11-09

Date terminated

2012-06-12

Location

W Henrietta, NY