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Proclear Toric (Omafilcon) Soft Contact Lens (2014-09-15)
- Starting date:
- September 15, 2014
- Posting date:
- October 1, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-41565
Recalled Products
Proclear Toric (Omafilcon) Soft Contact Lens
Reason
Technical customer complaints have been received related to the incorrect axis condition on Proclear Toric (PCT) product during the timeframe of 08/20/2012 to 02/17/2014. Up to 03/28/2014, a total of 38 technical complaints confirmed as incorrect axis have been associated with the root cause which is related to female insert rotation during the manufacturing process as a result of a damaged, loose, or missing setscrew that could ultimately result in an incorrect axis condition.
Affected products
Proclear Toric (Omafilcon) Soft Contact Lens
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
PROCLEAR TORIC
Companies
- Manufacturer
-
Coopervision Inc.
Southpoint, Hamble, Southampton
Hampshire
SO31 4RF
UNITED KINGDOM