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

Lot Number	F214034
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
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.There was no evidence to suggest that any aspect of this device was responsible for the reported issue after implantation.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.Once our medical monitor completes an assessment, a supplemental report will be issued.
Event or Problem Description
Lenstec received an complaint form via email stating "poor distal vision after surgery".
Event or Problem Description
Lenstec received an complaint form via email stating "poor distal vision after surgery".
Additional Manufacturer Narrative
Based on the review of the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Additionally, we have not received any other complaints from this batch.The assessment by lenstec's medical monitor suspected that this was either a biometry error or a patient anatomical error.There was no evidence to suggest that any aspect of this device was responsible for the reported poor distal vision after surgery.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 SBL-3
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer (Section G): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n.; st. petersburg, FL 33716 ; 7275712272
• MDR Report Key: 17627133
• Report Number: 9613160-2023-00013
• Device Sequence Number: 12588244
• Product Code: HQL
• UDI-Device Identifier: 00844369038409
• UDI-Public: 00844369038409
• 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: 2023
• 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): 09/13/2023

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 Lot Number: F214034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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