MAUDE Adverse Event Report: Lenstec Barbados Inc. Softec I; Intraocular Lens

Lot Number	253519
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Endophthalmitis (1835); Hypopyon (1913); Pupillary Block (2026); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Lenstec received an email stating "pt.Presented with tass (presumed).
Additional Manufacturer Narrative
An investigation is underway.Once additional information is available from the medical monitor assessment a supplemental report will be provided.

• Brand Name: Softec I
• Common Device Name: Intraocular Lens
• Manufacturer (Section D): Lenstec Barbados Inc.; airport commercial centre; pilgrim road; christ church, 17092 ; BB 17092
• Manufacturer (Section G): Lenstec Barbados Inc.; airport commercial centre; pilgrim road; christ church, 17092 ; BB 17092
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n.; st. petersburg, FL 33716 ; +1(727)571-2272
• MDR Report Key: 50181020
• Report Number: 9613160-2026-00050
• Device Sequence Number: 12850703
• Product Code: HQL
• UDI-Device Identifier: 00844369029308
• UDI-Public: 00844369029308
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2026

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 Lot Number: 253519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: 07/09/2026; 07/09/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 08/12/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown