MAUDE Adverse Event Report: LENSTEC BARBADOS INC.; CARTRIDGE

Lot Number	251800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the review of the documentation conducted, lenstec can confirm that all procedures in the manufacturing and packaging of the device were conducted correctly, and we have not received any other complaints from this batch.Based on the visual inspection performed, there were no defects noted on the returned cartridges and successful injection testing was performed using these returned cartridges and optical reject lenses without any damage to the lenses or the cartridges.No white film was present on the lenses after injection.Lenstec can confirm that our devices are 100% inspected at final clean and inspection and if any surface defects were present on the cartridge, it would not have been packed for shipping.Lenstec can further confirm that the cartridge, its design and the manufacturing processes 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, "white film on lenses noted on multiple patients, no serial numbers".

• Common Device Name: CARTRIDGE
• 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: 23077912
• Report Number: 9613160-2025-00047
• Device Sequence Number: 21266849
• Product Code: MSS
• UDI-Device Identifier: 00844369018975
• UDI-Public: 00844369018975
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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: 251800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• 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