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

Model Number	SOFTEC I
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	11/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After investigation of the complaint by the quality systems department, the results of lenstec's investigation are as follows; 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 lens had been conducted correctly.Batch reconciliation was 100.0%.This is the first complaint we have received relating to a lens from this batch.The lens remains implanted, therefore no specific device related testing can be performed and lenstec is unable to confirm the complaint.The examination notes detailing the doctor's findings were forwarded to lenstec's medical monitor for review.We are awaiting this review and any other additional information.When or if the lens is explanted, we have requested the lens return to lenstec for inspection.This complaint will remain open pending review from our medical monitor and any additional information received.Any additional information received will be provided in a supplemental report.
Event or Problem Description
Facility communicated with manufacturer about fibrous and very thick posterior capsule occuring following softec i implant in 2014.Later described as a film or thickness on the posterior part of the implant.Lens remains implanted.
Additional Manufacturer Narrative
After investigation of the complaint by the quality systems department, the results of lenstec's investigation remain as follows; 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 lens had been conducted correctly.Batch reconciliation was 100.0%.This is the first complaint we have received relating to a lens from this batch.The lens remains implanted; therefore, no specific device related testing can be performed and lenstec is unable to confirm the complaint.The examination notes detailing the doctor's findings were forwarded to lenstec's medical monitor for review.This supplemental report includes this assessment.The medical monitor reviewed patient and lens history and concurs with lenstec that there are no manufacturing, storage or performance concerns of this lens.Therefore, lenstec reiterates that there is no evidence to suggest a lens related occurrence.Any additional information received will be provided in an additional supplemental report.Device remains implanted.
Event or Problem Description
Facility communicated with manufacturer about fibrous and very thick posterior capsule occuring following softec i implant in 2014.Later described as a film or thickness on the posterior part of the implant.Lens remains implanted.This is a supplemental report for the described event with medical monitor assessment.

• 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: 6457393
• Report Number: 9613160-2017-00002
• Device Sequence Number: 580090
• Product Code: HQL
• UDI-Device Identifier: 00844369029360
• UDI-Public: 00844369029360
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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: 12/31/2018
• Device Model Number: SOFTEC I
• Device Lot Number: 135054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR