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LENTIS IOLs (2017-09-29)
- Starting date:
- September 29, 2017
- Posting date:
- November 24, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-65176
Affected products
A. LENTIS MPLUS X INTRAOCULAR LENS
B. LENTIS MPLUS INTRAOCULAR LENS
C. LENTIS COMFORT
Reason
Due to an increase of opacification complaints, Oculentis initiated a study to investigate the sporadic late postoperative opacification of LENTIS IOLs (completed August 30, 2017). The results of the study have indicated that surface calcification could possibly be the result of phosphate remnants originating from a phosphate containing detergent previously used in the cleaning process of the IOL from January 2012-May 2015.
Affected products
A. LENTIS MPLUS X INTRAOCULAR LENS
Lot or serial number
All serial numbers with expiry before 05/2020
Model or catalog number
LS-313 MF15
LS-313 MF30
Companies
- Manufacturer
-
OCULENTIS B.V.
KOLLERGANG 9
EERBEEK
6961 LZ
NETHERLANDS
http://
B. LENTIS MPLUS INTRAOCULAR LENS
Lot or serial number
All serial numbers with expiry before 05/2020
Model or catalog number
LS-313 MF15
LS-313 MF30
Companies
- Manufacturer
-
OCULENTIS B.V.
KOLLERGANG 9
EERBEEK
6961 LZ
NETHERLANDS
http://
C. LENTIS COMFORT
Lot or serial number
All serial numbers with expiry before 05/2020
Model or catalog number
LS-313 MF15
LS-313 MF30
Companies
- Manufacturer
-
OCULENTIS B.V.
KOLLERGANG 9
EERBEEK
6961 LZ
NETHERLANDS
http://