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

Model Number	VTICM5_12.6
Medical Device Problem Codes	Off-Label Use (1494); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6- type of investigation 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 vticm5_12.6 implantable collamer lens of diopter -9.00/2.5/069 (sphere/cylinder/axis) into the patients right eye (od) on (b)(6) 2024.Reportedly "ripped upon insertion.The lens was removed from the pts od with no complications.The backup lens was successfully inserted." the lens was implanted, removed and replaced with a backup lens of the same parameters and the problem was resolved.
Additional Manufacturer Narrative
B5- the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -9.00/2.5/069 (sphere/cylinder/axis) into the patients right eye (od) on (b)(6) 2024.Reportedly the lens got stuck in the cartridge and tore/broke during injection/delivery into the eye.There was patient contact but no patient injury.The lens was implanted, removed and replaced with a backup lens of the same parameters and the problem was resolved.Status of the eye: "mild corneal edema".The reporter indicated the cause of the event was the device.Lioli-24 injector.Lot# fck2001.H6- medical device problem code: 1494- off label use (age>45yrs) claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC 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: 19203839
• Report Number: 2023826-2024-01993
• Device Sequence Number: 18160614
• Product Code: QCB
• UDI-Device Identifier: 00841542114851
• UDI-Public: 00841542114851
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

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: 01/31/2025
• Device Model Number: VTICM5_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: 04/26/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/13/2024
• Date Device Manufactured: 02/26/2023
• 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# UNK; FOAM TIP PLUNGER (FTP), LOT# UNK; INJECTOR MODEL: LIOLI-24, LOT# FCK2001; MSI-PF, LOT# UNK
• Patient Age: 46 YR
• Patient Sex: Female