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

Model Number	VICM513.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that a 13.2mm vicm513.2 implantable collamer lens of a -12.0 was damaged with a tear in the corner.Patient contact or cause of the event is unknown.
Additional Manufacturer Narrative
A4-a6:unk.H6: work order search: one similar complaint within associated lots was found.Claim# (b)(4).
Additional Manufacturer Narrative
B5: product non-conformity (no patient involvement) was reported.Lens tore/broke before loading after opening the vial.Cause of the event was other with the device not performing as intended.Reportedly, "poor lens quality/edge torn." on (b)(6) 2024 a replacement lens was implanted into the patient's right eye (od).The problem was resolved.Claim# (b)(4).
Additional Manufacturer Narrative
B5: after futher reported information received.This claim is not reportable.There is no complaint.(b)(4).

• 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite: 210; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 19042118
• Report Number: 2023826-2024-01536
• Device Sequence Number: 20950381
• Product Code: MTA
• UDI-Device Identifier: 00841542119450
• UDI-Public: 00841542119450
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: VICM513.2
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 04/11/2024; 08/13/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/25/2024; 08/13/2024
• Date Device Manufactured: 03/17/2023
• 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: CARTIDGE MODEL: SFC-45 - LOT# 162676.; FOAM TIP PLUNGER - LOT# 1643206.; INJECTOER MODEL: LIOLI-24 - LOT# FC14401.; UNK.
• Patient Age: 45 YR
• Patient Sex: Female