MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); Phakic toric intraocular lens

Model Number	VTICMO_12.6
Medical Device Problem Code	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	09/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm vticmo 12.6 implantable collamer lens -15.50/+3.50/093 (sphere/cylinder/axis) into the patients left eye (os) on (b)(6) 2022.The lens was reported as having excessive vaulting, significant reduction of iridocorneal angles, and elevated iop.Cause of the event was unknown.On (b)(6) 2024 the lens was replaced with a smaller length lens.This resolved the problem.
Additional Manufacturer Narrative
H6: 4581: significant reduction of iridocorneal angles.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 18842377
• Report Number: 2023826-2024-01040
• Device Sequence Number: 20907167
• Product Code: QCB
• UDI-Device Identifier: 00840311324200
• UDI-Public: 00840311324200
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2024

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
• Device Expiration Date: 07/31/2025
• Device Model Number: VTICMO_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45, LOT# UNK; FOAM TIP PLUNGER, LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT#UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female