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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LENSTEC BARBADOS INC. SOFTEC I; INTRAOCULAR LENS
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LENSTEC BARBADOS INC. SOFTEC I; INTRAOCULAR LENS Back to Search Results
Lot Number 182647
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Capsular Bag Tear (2639)
Date of Event 03/12/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The lens was inspected at 1ox magnification under a stereoscopic microscope.The lens was seen with multiple dig outs on the optic and there was a partial tear on one of the haptics.This was probably caused by the removal of the lens from the eye with a sharp instrument.No other defects were seen on the lens.The cartridge was not returned for inspection, but the lens and this cartridge are compatible for implantation.There was no evidence to suggest that any aspect of the lens was responsible for the surgical complication reported.
 
Event or Problem Description
Lenstec received an email stating that "posterior capsule tear with zonular dehiscence.Patient left aphakic".
 
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Brand Name
SOFTEC I
Common Device Name
INTRAOCULAR LENS
Manufacturer (Section D)
LENSTEC BARBADOS INC.
airport commercial centre
pilgrim road
christ church,
BB 
MDR Report Key8556874
Report Number9613160-2019-00015
Device Sequence Number2308404
Product Code HQL
UDI-Device Identifier00844369029278
UDI-Public0844369029278
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P090022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date09/09/2023
Device Lot Number182647
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/22/2019
Initial Report FDA Received Date04/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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