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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LENSTEC BARBADOS INC. SOFTEC HD; INTRAOCULAR LENS
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LENSTEC BARBADOS INC. SOFTEC HD; INTRAOCULAR LENS Back to Search Results
Lot Number 181209
Medical Device Problem Code Device Handling Problem (3265)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/14/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Lenstec can confirm that all procedures in the manufacturing and packaging of the device were conducted correctly.After examination of the lens, the broken haptic was due to being handled in a dehydrated state.Furthermore, lenstec confirms that the lens, its design and the manufacturing process are not at fault due to the extensive testing that we have performed on this model.
 
Event or Problem Description
Lenstec received an email stating that "trailing haptic cut off during insertion.Lens explanted".
 
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Brand Name
SOFTEC HD
Common Device Name
INTRAOCULAR LENS
Manufacturer (Section D)
LENSTEC BARBADOS INC.
airport commercial centre
pilgrim road
christ church,
BB 
MDR Report Key8807167
Report Number9613160-2019-00021
Device Sequence Number326689
Product Code HQL
UDI-Device Identifier00844369027144
UDI-Public00844369027144
Combination Product (Y/N)N
Initial Reporter StateMO
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) 07/18/2019
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 Date06/19/2023
Device Lot Number181209
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/25/2019
Initial Report FDA Received Date07/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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