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

Lot Number	161333
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was inspected under a stereoscopic microscope at 15x magnification.The lens was received in three pieces, divided through the optic.When the pieces were placed together, it made a complete lens.The cross-section of the three broken pieces appeared jagged and rough indicative of cuts.No other defects, foreign materials or particles were seen on the lens.Another lens (serial number: (b)(4)) from inventory from the same batch was re-powered; this device was within specification.No defects were seen on the device.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 suspected lens investigation, the defects seen were a result of removing the lens from the eye.There was no evidence to suggest that any aspect of the lens was responsible for the vision loss experienced after surgery.Another lens from inventory was also investigated; this lens was within specification, including power, and no defects were seen.(b)(4).
Event or Problem Description
Lenstec, inc.Received an email notification stating "lens was explanted from patient 12 (b)(6) 2018.After going for a follow-up the patient was complaining that his vision was blurry so the doctor removed the lens.".

• 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: 8147835
• Report Number: 9613160-2018-00039
• Device Sequence Number: 19184023
• Product Code: HQL
• UDI-Device Identifier: 00844369039529
• UDI-Public: 00844369039529
• 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): 12/10/2018

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: 05/29/2021
• Device Lot Number: 161333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1