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

Model Number	SBL-3
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is under investigation.Once additional information is available a supplemental report will be submitted.
Event or Problem Description
Lenstec, inc.Received an email notification stating "iol was scratched.There was no patient injury and another lens was implanted.".
Event or Problem Description
Lenstec, inc.Received an email notification stating "iol was scratched.There was no patient injury and another lens was implanted.".
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.Additionally, we have not received any other complaints from these batches.Based on our investigation, lenstec concludes that the damage seen on the lens was probably to facilitate its removal from the eye.No scratch was seen on the returned lens as reported by the doctor.

• Brand Name: CLEARVIEW 3
• Common Device Name: INTRAOCULAR LENS- SBL-3
• 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: 20643201
• Report Number: 9613160-2024-00102
• Device Sequence Number: 7367761
• Product Code: MFK
• UDI-Device Identifier: 00844369038447
• UDI-Public: 00844369038447
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P200020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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 Model Number: SBL-3
• Device Lot Number: F223247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2022
• 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