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

Lot Number	251104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Red Eye(s) (2038); Uveitis (2122); Visual Impairment (2138); Photophobia (4801)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Lenstec received an email stating "implantation date: (b)(6) 2025.On the second day after the surgery, the patient's vision was normal, the distant vision was 0.6.On the (b)(6) 2025, the patient experienced a sudden decline in vision in the operated eye without any obvious cause, accompanied by photophobia, eye redness, and no eye pain.After physical examination, it was considered that the patient had uveitis after cataract surgery.".
Additional Manufacturer Narrative
Based on the initial report (documentation analysis, endotoxin check results and complaint history) and the subsequent 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.The assessment by lenstec's medical monitor stated that the iol had no role in this complaint, noting that the complaint is unable to be corroborated due to lack of testing and the lens remains implanted.Additionally, lenstec is unable to comment on the compatibility of the injector used.There was no evidence of contamination or fault in the device, supported by batch testing, endotoxin results, and the absence of similar complaints.Lenstec confirms that the lens design and manufacturing process were not responsible for the incident due to the extensive testing we have performed on this model.

• Brand Name: SOFTEC HD
• 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: 23524139
• Report Number: 9613160-2025-00051
• Device Sequence Number: 10187244
• Product Code: HQL
• UDI-Device Identifier: 00844369027298
• UDI-Public: 00844369027298
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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: 251104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VANCOMYCIN AND INTRAVITREAL INJECTION
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown