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

Lot Number	161307
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Irritation (1941); Visual Impairment (2138)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned in a biohazard bag in an alcon case.The lens was fully dehydrated and the biohazard bag was labelled with the ra #, diopter and model.No lenstec packaging components were received.Inspection was performed at 10x magnification under a stereoscopic microscope.The lens was cut in two across the optic.The lens was covered in what appeared to be salt crystals.The lens was hydrated and further inspection revealed that the lens was free of particles.Both haptics were intact and when the lens pieces were fitted together, a complete lens was formed.The cross-section of the cut was jagged and appeared to be a result of lens removal from the eye.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 lens had been conducted correctly.Batch reconciliation was 100.0%.The medical monitor reviewed the case and indicates this was likely due to a surgical circumstance that the haptic was outside of the capsular bag and not related to iol manufacturing or quality.There was no evidence to suggest that any aspect of the lens was responsible for the surgical complication reported.Lenstec therefore concludes that the event was not caused by the lens design.
Event or Problem Description
Lenstec received an email stating "lens tilted and irritating the iris per md.Iol exchange needed".

• Brand Name: SOFTEC HDM
• 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: 7459357
• Report Number: 9613160-2018-00020
• Device Sequence Number: 1067620
• Product Code: HQL
• UDI-Device Identifier: 00844369039338
• UDI-Public: 00844369039338
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

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: 05/17/2021
• Device Lot Number: 161307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1