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

Model Number	SOFTECI+20.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Loss (2142); Vitrectomy (2643); Zonular Dehiscence (2698)
Date of Event	08/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Furthermore, the visual inspection carried out indicated a broken haptic.The medical monitor indicated there was no evidence to suggest an iol dysfunction.Therefore, the conclusion reached was that no aspect of the lens was responsible for the surgical complication reported.Zonular dehiscence was present at time of surgery.
Event or Problem Description
Lenstec, inc.Received an email notification stating "upon insertion of lens, vitreous loss with zonular dehiscence.Lens removed, vitrectomy performed" no patient injury reported.

• Brand Name: SOFTEC I
• 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: 10024937
• Report Number: 9613160-2020-00013
• Device Sequence Number: 14156476
• Product Code: HQL
• UDI-Device Identifier: 00844369029445
• UDI-Public: 00844369029445
• 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): 05/04/2020

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: Health Professional
• Device Expiration Date: 06/06/2022
• Device Model Number: SOFTECI+20.0
• Device Catalogue Number: SOFTEC I
• Device Lot Number: 171642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1