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

Lot Number	231811
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
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.There was no evidence to suggests that any aspect of these devices was responsible for the reported incident.Additionally, the endotoxin results were within acceptable limits.
Event or Problem Description
Lenstec received an email stating "the patients had symptoms of tass after the surgery.There was patient injury and the lenses remain implanted.".
Event or Problem Description
Lenstec received an email stating "the patients had symptoms of tass after the surgery.There was patient injury and the lenses remain implanted.".
Additional Manufacturer Narrative
Based on the initial report (documentation analyses, 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 these devices was responsible for the reported incident.The assessment by lenstec's medical monitor stated that there are no details or similar cases from these batches to suggest that the iols are at fault in this case.Hence, no further action is 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.Assessment of the incident by lenstec's medical monitor the following observations were noted: 1 - the surgeon, had two patients in (b)(6) hospital suffer what was thought to be toxic anterior segment syndrome.One surgery was in 2023, while the other was in 2024.The reason for such late (i.E.More than one year postoperatively for each) reporting was not given.The iols were both softec hds and from separate non-outdated lots.The storage and handling of these common powers (+20.0 and +21.5 d) were not detailed.The preoperative risk factors, intraoperative surgical medications/consumables/reused instruments, and postoperative management were left out of the complaint.Lenstec has no associated complaints elsewhere that would implicate flawed manufacturing.2 - given the extreme lack of information, i have no reason to believe there is a lenstec-related role in this complaint.I would be happy to revisit it if concrete information arose.In the meantime, i am recommending no further action for this complaint.

• Brand Name: SOFTEC HD
• Common Device Name: INTRAOCULAR
• 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: 22500037
• Report Number: 9613160-2025-00027
• Device Sequence Number: 8477286
• 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: 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): 08/07/2025

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
• Operator of Device: Health Professional
• Device Lot Number: 231811
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2023
• 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