MAUDE Adverse Event Report: LENSTEC BARBADOS INC. CLEARVIEW 3; INTRAOCULAR LENS

Model Number	SBL-3
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.All lenses are placed into the delivery systems in our final clean department and inspected, before being torqued and labelled.As the packaging components were not returned, lenstec was unable to draw a conclusion as to why the lens was not in the delivery system.However, lenstec has various procedures and checks in place to ensure that the lens is always present within each delivery system.As such, it is highly unlikely that a lens would fall from the delivery system after being shipped to the customer.The device was discarded at the facility, we are therefore unable to determine what would have caused the rip in the haptic.However, 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.Furthermore, the cart45s cartridge used and the sbl-3 +22.25d lens are compatible and once the instructions for use are followed, successful implantation should occur without incident.
Event or Problem Description
Lenstec received an e-mail stating that "the lens was found stuck to the bottom of the vial." implant / explant date on (b)(6) 2025 due to rip in the haptic.A new lens was implanted.The cart45s cartridge was used - lot#: unknown.The lens was discarded at the facility.

• Brand Name: CLEARVIEW 3
• 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: 21941806
• Report Number: 9613160-2025-00014
• Device Sequence Number: 12961794
• Product Code: MFK
• UDI-Device Identifier: 00844369038393
• UDI-Public: 00844369038393
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P200020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 04/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SBL-3
• Device Lot Number: SB16078
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2023
• 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