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Sensar and Tecnis IOL Various (2016-08-30)
- Starting date:
- August 30, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-60152
Affected Products
- Sensar Foldable IOL With OptiEdge
- Tecnis 1-Piece IOLWith Tecnis LTEC Preloaded Delivery System
- Tecnis Symfony Extended Range Of Vision IOL
- Tecnis 1-Piece Acrylic Aspheric IOL
Reason
AMO is initiating this action due to detection of an inspection equipment malfunction that resulted in a total of 58 distributed lenses not being fully checked prior to release. It has been identified that this malfunction may result in the release of mislabelled intraocular lenses. Use of a mislabelled intraocular lens could lead to potential unexpected postoperative refractive error and may result in a secondary surgical intervention. Intraocular lenses with serial numbers included in the recall letter that have been implanted and resulted in an appropriate post-op refractive outcome are not affected by this action.
Affected products
A. Sensar Foldable IOL With OptiEdge
Lot or serial number
- 2015871503
Model or catalog number
- AR40E
Companies
- Manufacturer
-
Abbott Medical Optics, Inc.
1700 E. St. Andrew Place
Santa Ana
92705
California
UNITED STATES
B. Tecnis 1-Piece IOLWith Tecnis LTEC Preloaded Delivery System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- PCB00
Companies
- Manufacturer
-
Abbott Medical Optics, Inc.
1700 E. St. Andrew Place
Santa Ana
92705
California
UNITED STATES
C. Tecnis Symfony Extended Range Of Vision IOL
Lot or serial number
- 8496921508
Model or catalog number
- ZXR00
Companies
- Manufacturer
-
Abbott Medical Optics, Inc.
1700 E. St. Andrew Place
Santa Ana
92705
California
UNITED STATES
D. Tecnis 1-Piece Acrylic Aspheric IOL
Lot or serial number
- 5152461501
- 5152481501
- 5152501501
- 5152541501
- 5152561501
- 5152581501
- 5152601501
- 5152621501
- 5152641501
- 5152661501
Model or catalog number
- ZCB00
Companies
- Manufacturer
-
Abbott Medical Optics, Inc.
1700 E. St. Andrew Place
Santa Ana
92705
California
UNITED STATES