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

Model Number	SBL-3+21.75
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Eye / Vision Problem (4471); Insufficient Information (4580)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no evidence to suggest that any aspect of this device was responsible for the reported inflammation and an investigation is on-going.The device remains implanted.A supplemental report will be submitted once additional requested information is provided along with review from medical monitor.
Event or Problem Description
Lenstec received an email stating "after cataract surgery in left eye of preclinical patients with comparative glaucoma, the first day visual acuity was 0.6.Pupillary exudation appeared in the left eye nine days after surgery.Lens remains implanted and no reported patient injury.".
Additional Manufacturer Narrative
There is no evidence to suggest that any aspect of this device was responsible for the reported inflammation.The device remains implanted.The assessment from medical monitor concluded there was no evidence to indicate the iol as the source of the reported incident.
Event or Problem Description
Lenstec received an email stating "after cataract surgery in left eye of preclinical patients with comparative glaucoma, the first day visual acuity was 0.6.Pupillary exudation appeared in the left eye nine days after surgery.Lens remains implanted and no reported patient injury.".

• 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: 16152980
• Report Number: 9613160-2023-00002
• Device Sequence Number: 17886760
• 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: 2022
• 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): 02/02/2023

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 Expiration Date: 09/08/2025
• Device Model Number: SBL-3+21.75
• Device Catalogue Number: SBL-3
• Device Lot Number: SB10029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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