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

Model Number	SBL-3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the review of the batch documentation conducted, lenstec can confirm that all procedures in the manufacturing and packaging of the devices were conducted correctly.No errors or discrepancies were found and we can confirm that the labelled power was correct.Additionally, we have not received any other complaints from these batches.
Event or Problem Description
Lenstec barbados inc.Received an email notification stating "the postoperative result showed that the refractive outcome did not match the expected lens power".

• Brand Name: CLEARVIEW 3
• Common Device Name: SBL-3 INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, 17092 ; BB 17092
• Manufacturer (Section G): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, 17092 ; BB 17092
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n.; st. petersburg, FL 33716 ; 7275712272
• MDR Report Key: 23597934
• Report Number: 9613160-2025-00054
• Device Sequence Number: 18470700
• Product Code: MFK
• UDI-Device Identifier: 00844369038317
• UDI-Public: 00844369038317
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: P200020
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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
• Device Model Number: SBL-3
• Device Lot Number: F243931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2025
• 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