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

Model Number	SBL-3
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Lenstec received an email stating "trailing haptic was torn and removed then replaced.No harm was done to the patient.
Additional Manufacturer Narrative
The device was destroyed at the facility, therefore will not be returned to lenstec.As additional investigation is completed a supplemental report will be issued.
Event or Problem Description
Lenstec received an email stating "trailing haptic was torn and removed then replaced.No harm was done to the patient.".
Additional Manufacturer Narrative
Based on the review of the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the device were conducted correctly, and we have not received any other similar complaints from this batch.Based on the investigation, lenstec is unable to provide a specific cause as to how the haptic broke during the surgery.The lens was returned in two pieces.Both pieces consisted of half of the optic and broken haptics.The cross sections appeared smooth and straight and appeared to be cut with a sharp object.This damage was probably done to facilitate the removal of the lens from the eye, and hence we were unable to identify the area where the haptic broke to properly determine the cause.Additionally, 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.

• 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: 22021057
• Report Number: 9613160-2025-00017
• Device Sequence Number: 8733985
• Product Code: MFK
• UDI-Device Identifier: 00844369038317
• UDI-Public: 00844369038317
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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 Model Number: SBL-3
• Device Lot Number: SB18705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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