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

Lot Number	162439
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was inspected at 15x magnification under a stereoscopic microscope.The lens was in two pieces, separated by a cut through the optic.This cut was probably done to facilitate the removal of the lens from the eye.When the pieces were fitted together they made one complete lens.No foreign material, particles or other defects were noted.A power test could not be performed due to the state of the returned lens.Based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.In terms of the investigation, the defect seen was probably because of removing the lens from the eye.There was no evidence to suggest that any aspect of the lens was responsible for the patient not seeing properly.Lenstec is therefore unable to determine a specific cause for this incident.Due to the state of the returned lens, a power test could not be performed and hence, no conclusion could be made with regards to the power of the returned lens.However, the batch documentation revealed that the lens was within the tolerance range for +20.5d.Additionally, lenstec believes 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 "patient complained about not seeing clearly.The lens was implanted on (b)(6) 2019 and was explanted (b)(6) 2019.The doctor implanted a softec hdm +18.5d lens with no adverse event.The doctor requested to have the power of the lens verfied".

• Brand Name: SOFTEC HDM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 8577779
• Report Number: 9613160-2019-00016
• Device Sequence Number: 1586746
• Product Code: HQL
• UDI-Device Identifier: 00844369039321
• UDI-Public: 00844369039321
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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 Date: 08/24/2021
• Device Lot Number: 162439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1