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

Lot Number	161705
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned in the vial in three pieces.The vial was enclosed in a biohazard bag and the bag was labelled with the ra #, diopter and model.No other lenstec packaging components were received.Inspection was performed at 10x magnification under a stereoscopic microscope.The lens was found in three pieces separated by the optic.Two pieces were made of an intact haptic and one piece of the optic whilst the third piece was just part of the optic.A complete lens could not be formed when the pieces were placed together.The cross-sectional inspection of each piece was jagged and appeared to be cut to remove the lens from the eye.No other defects were noted.As the lens was in three pieces, we were unable to conduct a power test.However, 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 an exchange for refractive reasons.Although we were unable to conduct power testing of the lens due to the condition in which it was returned, we can confirm that all our manufacturing documentation indicated that the lens was correctly labelled and all operations done as required.There was no evidence to support the lens being the cause of the myopic result reported.
Event or Problem Description
Lenstec received an email stating "lens was implanted.Patient had a myopic result.Doctor removed the lens, did not have to enlarge the incision.

• 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: 7459367
• Report Number: 9613160-2018-00019
• Device Sequence Number: 13733438
• Product Code: HQL
• UDI-Device Identifier: 00844369039475
• UDI-Public: 00844369039475
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2018

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: 06/02/2021
• Device Lot Number: 161705
• 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