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

Lot Number	170830
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After the lens was returned, a visual inspection was carried out on the lens using the stereoscopic microscope at 15x magnification.No foreign material was present.The lens was returned in two pieces, separated by a jagged cut through the optic.Both haptics were intact and no other defects were found.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%.There were no other complaints received for this batch.After having carried out a detailed investigation of the lens in question, the break on the optic suggest that the lens was cut, possibly to facilitate removal of the lens from the eye.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 notification from the user facility with the following "lens injected and turned upside down in eye.Dr.Tried to turn it over, but the capsule ruptured.Doctor cut out lens and inserted a 3- piece 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: 7444817
• Report Number: 9613160-2018-00018
• Device Sequence Number: 1963139
• Product Code: HQL
• UDI-Device Identifier: 00844369027359
• UDI-Public: 00844369027359
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/19/2018

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: 04/02/2022
• Device Lot Number: 170830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1