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VALVED CANNULAS BY ALCON (2015-08-21)
- Starting date:
- August 21, 2015
- Posting date:
- September 8, 2015
- 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-54942
Affected Products
A. VALVED TROCAR CANNULA ENTRY SYSTEM
B. CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK
C. CONSTELLATION VISION SYSTEM TOTAL PLUS VITRECTOMY PAK
D. CONSTELLATION SYSTEM, TOTAL PLUS COMBINED PROCEDURE PAK
Reason
Alcon has discovered that a small percentage of the valved cannulas have the potential to leak beyond their design specification.
Affected products
A. VALVED TROCAR CANNULA ENTRY SYSTEM
Lot or serial number
N/A
Model or catalog number
8065-7515-85
8065-7515-86
8065-7516-57
8065-7516-58
8065751778
8065751801
Companies
- Manufacturer
-
Alcon Laboratories Inc.
6201 South Freeway
Fort Worth
Texas
UNITED STATES
B. CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK
Lot or serial number
N/A
Model or catalog number
14501-05
14502-06
14503-04
14512-05
14540-03
14541-06
14550-07
14580-07
14581-04
14582-04
14597-04
14603-09
14669-06
14672-05
14955-03
15158-02
15318-04
15324-01
15455-05
15456-03
15464-02
15465-02
15525-01
15553-03
15722-03
15723-03
16444-01
16446-01
16447-01
16467-01
16496-02
16497-01
16498-01
16498-02
16559-01
16630-01
Companies
- Manufacturer
-
Alcon Laboratories Inc.
6201 South Freeway
Fort Worth
Texas
UNITED STATES
C. CONSTELLATION VISION SYSTEM TOTAL PLUS VITRECTOMY PAK
Lot or serial number
N/A
Model or catalog number
8065751900
8065751901
8065751902
8065751903
Companies
- Manufacturer
-
Alcon Laboratories Inc.
6201 South Freeway
Fort Worth
Texas
UNITED STATES
D. CONSTELLATION SYSTEM, TOTAL PLUS COMBINED PROCEDURE PAK
Lot or serial number
N/A
Model or catalog number
8065751908
8065751910
Companies
- Manufacturer
-
Alcon Laboratories Inc.
6201 South Freeway
Fort Worth
Texas
UNITED STATES