MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS; LENS, INTRAOCULAR, PHAKIC

Model Number	VICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6- investigation type 4110: lens work order search-no similar complaints reported for units within the same lot.Claim (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm vicm5 12.6 implantable collamer lens -9.5 diopter into the patient's right eye (od) on (b)(6) 2023 after it was stuck in the cartridge/injector and was damaged on delivery.The lens was reported as having low vaulting without rotation.On (b)(6) 2024 the lens was replaced with a longer length lens.This resolved the problem.Cause of the event was the device.The device did not fail to perform as intended.
Additional Manufacturer Narrative
B2: corrected to: date of birth, (b)(6) 1994 in the intial mdrs.B4: corrected to: (b)(6) 2024 in the initial mdrs.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Common Device Name: LENS, INTRAOCULAR, PHAKIC
• 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 muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 19628953
• Report Number: 2023826-2024-02574
• Device Sequence Number: 18276573
• Product Code: MTA
• UDI-Device Identifier: 00840311300594
• UDI-Public: 00840311300594
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 05/30/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: VICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/23/2024
• Date Device Manufactured: 10/09/2023
• 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 Sex: Unknown