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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 SB05056
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/12/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Based on the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Based on the visual inspection carried out, the damage on the lens optic appeared to be a cut to facilitate the removal of the lens from the eye.There was no evidence to suggest that any aspect of the lens was responsible for the surgical complication reported.(b)(4).
 
Event or Problem Description
Lenstec, inc.Received an email notification stating "lens was implanted and doctor removed as posterior capsule rupture occurred.Implanted a starr cq lens, no stitches were needed and no adverse event with patient".
 
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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, BB170 92,
BB  BB17092,
MDR Report Key8411596
Report Number9613160-2019-00010
Device Sequence Number1795399
Product Code HQL
UDI-Device Identifier00844369029384
UDI-Public00844369029384
Combination Product (Y/N)N
Initial Reporter StateCA
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) 03/11/2019
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 Date11/01/2023
Device Lot NumberSB05056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/12/2019
Initial Report FDA Received Date03/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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