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

Lot Number	SB19473
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uveitis (2122)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device reported remains implanted and therefore, not returned to lenstec.However, there is no evidence to suggest that any aspect of this device was responsible for the reported event.As additional investigation is completed a supplemental report will be issued.
Event or Problem Description
Lenstec received an email stating "the patient had sudden congestion and visual fog symptoms in the right eye".
Additional Manufacturer Narrative
Based on the initial report (documentation analysis, endotoxin check results and complaint history) and the assessment by lenstec's medical monitor, lenstec concludes that there was no evidence to suggest that any aspect of this device was responsible for the reported incident.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.
Event or Problem Description
Lenstec received an email stating "the patient had sudden congestion and visual fog symptoms in the right eye".

• Brand Name: SOFTEC HD PLI
• 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 ; 7275712272
• MDR Report Key: 21970539
• Report Number: 9613160-2025-00016
• Device Sequence Number: 20898110
• Product Code: HQL
• UDI-Device Identifier: 00844369002677
• UDI-Public: 00844369002677
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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?: No
• Operator of Device: Health Professional
• Device Lot Number: SB19473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DICLOFENAC SODIUM EYE DROPS; DICLOFENAC SODIUM EYE DROPS; LEVOFLOXACIN EYE GEL; LEVOFLOXACIN EYE GEL; TOBRAMYCIN DEXAMETHASONE EYE DROPS; TOBRAMYCIN DEXAMETHASONE EYE DROPS
• Patient Sex: Unknown