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

Model Number	VICM5 13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Claim#(b)(4).
Event or Problem Description
A facility representative reported during an implantable collamer lens (icl) implantation procedure the lens flipped.The backup lens was used.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.
Event or Problem Description
A facility representative reported during an implantable collamer lens (icl) implantation procedure the lens flipped.The backup lens was used.The lens was implanted, removed and replaced intraoperatively with back lens.The problem was resolved.Reportedly, "no complications from a removing the upside-down icl and replacing," and "icl good position and cornea clear.".
Additional Manufacturer Narrative
Correction and new data entered throughout form.D4 - primary unique device indentifier (udi)#: (b)(4)."udi related data quality updates only" claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER DEVICE (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: 19925105
• Report Number: 2023826-2024-03295
• Device Sequence Number: 18163562
• Product Code: MTA
• UDI-Device Identifier: 00840311300976
• UDI-Public: (01)00840311300976(11)230909(17)260831(21)S2135166
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 10/04/2024
• Date Device Manufactured: 09/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female