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

Model Number	VICM5_13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -12.0 into the patient's right eye (od) on (b)(6) 2023.The lens was removed on (b)(6) 2023 due to low vault.That same day, the lens was replaced with a longer length lens although it is unclear whether this was within the same procedure.The problem was resolved.Cause of event reported as unknown.
Additional Manufacturer Narrative
Additional information: b3- date of event: 17-may-2023.B5- updated to reflect an exchange.H6 health effect - impact code: changed to 4629.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -12.0 into the patient's right eye (od) on (b)(6) 2023.It was confirmed that the lens was exchanged for a longer length lens on (b)(6) 2023 due to low vault.The problem was resolved.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC 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 ; 6263037902
• MDR Report Key: 17313138
• Report Number: 2023826-2023-02814
• Device Sequence Number: 4036815
• Product Code: MTA
• UDI-Device Identifier: 00840311300976
• UDI-Public: 00840311300976
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2023

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: 08/31/2025
• Device Model Number: VICM5_13.2
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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 (FTP), LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female