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

Model Number	SOFTECHD+20.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	05/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A full audit of all batch documentation relating to the production of the devices was performed.The audit concluded that all procedures in manufacturing and packaging of the devices had been conducted correctly.Batch reconciliation was 100.0%.Based on the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.There was no evidence to suggest that any aspect of the lens was responsible for the surgical complication reported.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.Lenstec has also conducted extensive testing on the lens model and the instruments used and our results indicate that these devices are compatible.
Event or Problem Description
Lenstec received an email notification indicating "capsule ruptured after insertion.Md decided to change to sulcus 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: 10106463
• Report Number: 9613160-2020-00051
• Device Sequence Number: 19657694
• Product Code: HQL
• UDI-Device Identifier: 00844369027311
• UDI-Public: 00844369027311
• Combination Product (Y/N): N
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2020

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: No Information
• Device Expiration Date: 02/21/2022
• Device Model Number: SOFTECHD+20.5
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: SB03132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2017
• Initial Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1