MAUDE Adverse Event Report: Lenstec Barbados Inc. ClearView 3; Intraocular Lens

Model Number	SBL-3
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Lenstec received an email stating " lens appeared cloudy.There was no patient contact.".
Additional Manufacturer Narrative
Lenstec is investigating and once lens is returned to manufacturer a supplemental report will be issued.

• Brand Name: ClearView 3
• Common Device Name: 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 ; +1(272)571-2272
• MDR Report Key: 50820182
• Report Number: 9613160-2026-00059
• Device Sequence Number: 13432003
• Product Code: MFK
• UDI-Device Identifier: 00844369038294
• UDI-Public: 00844369038294
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P200020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: SB21886
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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