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	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens of diopter -9.00 into the patients left eye (os) on (b)(6) 2024.The lens tore/broke during injection/delivery into the eye.There was patient contact but no patient injury.The lens was implanted and removed intraoperatively.On the same day a backup lens of the same parameters was implanted and the problem was resolved.Status of the eye: "doing very well".The reporter indicated the cause of the event was the user error and the device did not fail to perform as intended.Cause details provided: "lens was injected halfway into the eye, during remove with forceps piece of lens tore off".

• 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 ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 19353343
• Report Number: 2023826-2024-02305
• Device Sequence Number: 7724474
• Product Code: MTA
• UDI-Device Identifier: 00840311300587
• UDI-Public: 00840311300587
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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: 08/31/2026
• Device Model Number: VICM5_12.6
• 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: 05/14/2024
• Initial Report FDA Received Date: 05/20/2024
• Date Device Manufactured: 09/29/2023
• 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# 1635505; FOAM TIP PLUNGER (FTP), LOT# UNK; MSI-PF, LOT# 1625165
• Patient Age: 31 YR
• Patient Sex: Female