MAUDE Adverse Event Report: LENSTEC BARBADOS INC. SOFTEC I; INTRAOCULAR LENS

Lot Number	172529
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A visual inspection was carried out using the stereoscopic microscope set to x 10 magnification.The lens was cut in half with both haptics intact.The lens was hydrated to facilitate further inspection.Some white particles were seen on the lens; the lens was cleaned with a swab and these particles were removed.The lens carried some punctured marks in the optic, probably because of handling.The cross-sectional inspection of the two halves of the lens were jagged and appeared to be cut to facilitate lens removal.No other defects were noted.A full audit of all batch documentation relating to the production of the lens was performed.The audit concluded that all procedures in manufacturing and packaging of the lenses had been conducted correctly.Batch reconciliation was 100.0%.Additionally, lenstec has not received any other complaints from this batch.After having carried out a detailed investigation of the lens in question, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Lenstec is unable to determine what deposits were seen by the doctor as the lens only carried white particles which resulted from the solution drying on the lens.These particles were easily removed.Lenstec has procedures in place to ensure that only devices which met our final clean and inspection criteria would be shipped to our customers and any contaminated lenses would not have met our criteria.The jagged breaks on the lens appeared to be cuts to facilitate lens removal.[(b)(4)].
Event or Problem Description
Lenstec inc received an email stating that "one month post op, the doctor saw "deposits" on the posterior side of the lens.Could only be visualized at slit lamp.We performed an iol exchange.This lens- looks clear now is available to come back" the incision was not enlarged to remove the iol and there was no patient injury".

• 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 Key: 7512628
• Report Number: 9613160-2018-00022
• Device Sequence Number: 218002
• Product Code: HQL
• UDI-Device Identifier: 00844369029384
• UDI-Public: 00844369029384
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

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 Date: 09/04/2022
• Device Lot Number: 172529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1