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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 171660
Health Effect - Clinical Code Corneal Clouding/Hazing (1878)
Date of Event 12/08/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Distributor reported the softec i iol appeared "hazy" under slit-lamp after operation, however, the lens remains implanted.Lenstec completed a batch review and no discrepancies were found as it relates to batch documentation analysis.The audit determined that all procedures in the manufacturing and packaging of the device had been carried out correctly.Batch reconciliation was 100%.No other tests could be completed as the lens remains implanted.Once additional information about the event is obtained, a supplemental report will be filed.
 
Event or Problem Description
Iol reported to be "hazy" under slit lamp after operation.
 
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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 Key7169937
Report Number9613160-2018-00001
Device Sequence Number918061
Product Code HQL
UDI-Device Identifier00844369029544
UDI-Public00844369029544
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P090022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/05/2018
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 Physician
Device Expiration Date06/22/2019
Device Lot Number171660
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/08/2017
Initial Report FDA Received Date01/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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