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

Lot Number	144235
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lenstec inc received the lens and a visual inspection was carried out on the device using the stereoscopic microscope set to l5x magnification.The lens was intact, but a circular haze was seen on the center of one side of the optic.No foreign particles were seen on the lens.The lens was cleaned with purified water and the haze remained on the surface of the optic.Since the haze remained the 1% alzarin solution was prepared to carry out the calcium test.No other defects were noted on the lens.The lens did not stain for calcium.A superficial surface haze remained on the lens.The matrix of the lens was clear.The medical monitor review determined that patient factors relating to previous glaucoma surgeries including the variety of unusual maneuvers (i.E.Disruption of blood aqueous barrier, usage of probable air bubble, ovds, and anti-scarring agents like mitomycin c) are likely to blame.Furthermore, there were no manufacturing/batch concerns from this lot of iols.Based on the investigation previously carried out (documentation analysis, complaint history and investigation of the returned lens) and the assessment from our medical monitor, lenstec concludes that there is no evidence to suggest that the lens is at fault.(b)(4).
Event or Problem Description
Lenstec received the return goods form with the event stated "there was anterior capsular opacities on the surface of the lens".

• Brand Name: SOFTEC HD
• 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: 7791039
• Report Number: 9613160-2018-00031
• Device Sequence Number: 1287124
• Product Code: HQL
• UDI-Device Identifier: 00844369027342
• UDI-Public: 00844369027342
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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: Health Professional
• Device Expiration Date: 11/12/2019
• Device Lot Number: 144235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1