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); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Lenstec received an email stating "patient developed tass symptoms after surgery.".
Additional Manufacturer Narrative
Lenstec is awaiting addiitional information, once received a supplemental report will be submitted.The lens remains implanted.Additionally, lenstec is unable to comment on the compatibility of the injector used (lp604350c) or the sterilization practices of the user of this injector or other instruments used during surgery.
Event or Problem Description
Lenstec received an email stating "patient developed tass symptoms after surgery.".
Additional Manufacturer Narrative
Based on the investigation previously carried out, lenstec re-iterates that there was no evidence to suggest that any aspect of these devices was responsible for the reported incident.The endotoxin results were within acceptable limits, no further action is recommended.Additionally, lenstec cannot comment on the compatibility of the injector used (b)(6) or the sterilization practices of the user of this injector.Furthermore, 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: 21604904
• Report Number: 9613160-2025-00007
• Device Sequence Number: 13080208
• Product Code: MFK
• UDI-Device Identifier: 00844369038379
• UDI-Public: 00844369038379
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P200020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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: SB18002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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