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

Lot Number	SB21418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Lenstec received an email stating "the patients had symptoms of tass after the surgery.The symptoms are a large amount of spider-web-like exudation in the anterior chamber, inflammation and a significant decline in vision.There was patient injury and the lenses remain implanted.".
Additional Manufacturer Narrative
Based on the investigation conducted, lenstec concludes that there was no evidence to suggest that any aspect of these devices was responsible for the reported incident.The assessment by lenstec's medical monitor stated the photos were helpful, but the etiology of tass in the complaint is not conclusive.It was also noted that the iols may be an innocent bystander for tass caused by other reasons, and the lack of similar cases around the globe, gives pause to blame the intraocular lenses.Hence, no further actions other than continued vigilance and process reviews were recommended.Furthermore, lenstec confirms 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.The compatibility and sterility of the injector used by end user cannot be corroborated by lenstec.

• Brand Name: SOFTEC HDO
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commerical centre; pilgram road; christ church, BB170 92; BB BB17092
• Manufacturer (Section G): LENSTEC BARBADOS INC.; airport commerical centre; pilgram road; christ church, BB170 92; BB BB17092
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n.; st. petersburg, FL 33716 ; 7275712272
• MDR Report Key: 22982264
• Report Number: 9613160-2025-00041
• Device Sequence Number: 8972834
• Product Code: HQL
• UDI-Device Identifier: 00844369037372
• UDI-Public: 00844369037372
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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?: Yes
• Device Lot Number: SB21418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2025
• 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