MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS

Model Number	VTICMO12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - health effect clinical code: 4581 - angle closure.H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vticmo12.6, -15.0/+1.5/072 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.The patient experienced angle closure with elevated intraocular pressure and on (b)(6) 2023 an addition of new pi (yag) was performed.Lens remains implanted.A follow up will be performed was noted by the surgeon.
Additional Manufacturer Narrative
B5 - the reporter indicated that the surgeon implanted a 12.6mm vticmo12.6, -15.0/+1.5/072 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.The patient experienced excessive vaulting with elevated intraocular pressure.The lens was exchanged for a shorter length lens on (b)(6) 2023.This resoved the problem.H6 - code 4581 - angle clousre, should be removed.H6- code 4625 - yag, should be removed.Claim #: (b)(4).
Additional Manufacturer Narrative
B5 - it was later clarified that the problem was not resolved.Claim#: (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned in a vial in liquid with residue/debris on the product.Visual inspection found haptic broken.Dimensional inspection found the lens to be within specifications.Claim # (b)(4).
Additional Manufacturer Narrative
B3: event date is "27-aug-2023" on the inital mdr, it should be corrected to "27-jun-2023".Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17916405
• Report Number: 2023826-2023-04520
• Device Sequence Number: 12457981
• Product Code: QCB
• UDI-Device Identifier: 00840311322763
• UDI-Public: 00840311322763
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/09/2023

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: 10/31/2025
• Device Model Number: VTICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/25/2023; 10/25/2023; 12/27/2023; 01/18/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 10/30/2023; 12/04/2023; 01/11/2024; 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT#-UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male