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

Model Number	VICM5 12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that the surgeon implanted, removed, and replaced a 12.6mm vicm5 12.6.-13.0 diopter implantable collamer lens into the patient's left eye (os) on (b)(6) 2024.The lens tore/broke during injection/delivery into the eye.There was patient contact(lens touched the eye).No patient injury.The lens was implanted, removed, and replaced intraoperatively.This resolved the problem.
Additional Manufacturer Narrative
A4 - unk.A5 - unk.A6 - unk.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned in vial, with moisture and debris on product.Visual inspection found haptic torn and debris on the lens.Claim# (b)(4).
Additional Manufacturer Narrative
Correction of information: h11 - corrected data: d4: reported as: (b)(4).Correct to: primary unique device identifier (udi)#: (b)(4)."udi related data quality updates only".Additional information: h6- device history record (dhr) review; the dhr review indicates that the product has been manufactured within the established process parameters and that there is no indication that the manufacturing and/or processing of the device contributed to the complaint issue.Claim# (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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 19308615
• Report Number: 2023826-2024-02223
• Device Sequence Number: 7321340
• Product Code: MTA
• UDI-Device Identifier: 00840311300662
• UDI-Public: 00840311300662
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 04/25/2024

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: 09/30/2026
• Device Model Number: VICM5 12.6
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 09/23/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 09/04/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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: CARTRIDGE MODEL#SFC-45, LOT#1654298.; FOAMTIPPLUNGER MODEL#FTP, LOT#1710696.; INJECTOR MODEL#MSI-PF, LOT#1709477.
• Patient Age: 39 YR
• Patient Sex: Male