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

Model Number	VTICM5_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	02/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of a -9.5/1.5/91 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6) 2023.The lens was intraoperatively implanted, removed, and replaced due to a lens tear/break during injection/delivery into the eye.There was patient contact, but no patient injury.Reportedly, "eye is quiet," and "loading and surgery went off well with no outwards incident." the problem was resolved.
Additional Manufacturer Narrative
Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -9.5/+1.5/91 (sphere/cylinder/axis) into the patients right eye (od) on (b)(6) 2023.Reportedly the lens tore/broke during injection/delivery into the eye.There was no patient injury.The lens was implanted and removed intraoperatively.On (b)(4) 2023 the same model and length was implanted and the problem was resolved.The status of the eye was reported as "eye quiet' and it was reported that "loading and surgery went off well with no untowards incident'.Reportedly "lens got stuck in the plunger while implanting and got torn'.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 enriquez ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 16523649
• Report Number: 2023826-2023-00633
• Device Sequence Number: 2315802
• Product Code: QCB
• UDI-Device Identifier: 00840311311453
• UDI-Public: 00840311311453
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 02/09/2023

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: 08/31/2025
• Device Model Number: VTICM5_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: 02/09/2023
• Supplement Date Received by Manufacturer: 04/14/2023; 04/18/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/14/2023; 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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 - LOT# UNK.; INJECTOR MODEL: MSI-PF - LOT# UNK.
• Patient Sex: Male