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

Lot Number	235211
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Red Eye(s) (2038); Blurred Vision (2137); Eye Pain (4467)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Lenstec received an email stating "the patient reported eye red and pain, blurred vision.".
Additional Manufacturer Narrative
Lenstec is awaiting addiitional information, once received a supplemental report will be submitted.The lens remains implanted.
Additional Manufacturer Narrative
Based on the review of the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the devices were conducted correctly.The endotoxin results were within acceptable limits and we have not received any other complaints from this batch.There was no evidence to suggest that any aspect of the 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 reported eye red and pain, blurred vision.".

• Brand Name: SOFTEC HD
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, BB170 92; BB BB17092
• Manufacturer (Section G): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, BB170 92; BB BB17092
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n.; st. petersburg, FL 33716 ; 7275712272
• MDR Report Key: 21249182
• Report Number: 9613160-2025-00001
• Device Sequence Number: 20884525
• Product Code: HQL
• UDI-Device Identifier: 00844369027311
• UDI-Public: 00844369027311
• 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: 2024
• 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): 02/20/2025

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: 235211
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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: ATROPINE SULFATE EYE GEL; ATROPINE SULFATE EYE GEL; COMPOUND TROPICAMIDE EYE DROPS; COMPOUND TROPICAMIDE EYE DROPS; DICLOFENAC SODIUM EYE DROPS; DICLOFENAC SODIUM EYE DROPS; LEVOFLOXACIN EYE DROPS; LEVOFLOXACIN EYE DROPS; METHYLPREDNISOLONE SODIUM SUCCINATE; METHYLPREDNISOLONE SODIUM SUCCINATE; TOBRAMYCIN DEXAMETHASONE EYE DROPS; TOBRAMYCIN DEXAMETHASONE EYE DROPS
• Patient Sex: Unknown