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

Model Number	VTICM5_13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -12.00/2.0/091 (sphere/cylinder/axis) into the patient's right eye (od).The patient experienced an excessive vault.The lens was explanted.A replacement lens of a shorter length lens was implanted and the problem was resolved.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional data: b5- the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -12.00/2.0/091 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023.The patient experienced an excessive vault.On (b)(6) 2023 the lens was explanted.A replacement lens of a shorter length lens was implanted and the problem was resolved.Claim# (b)(4).
Additional Manufacturer Narrative
Additional data: h6- health effect- impact code (f): "4627" should be removed and "4629" should be added.B5- the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -12.00/2.0/091 (sphere/cylinder/axis) into the patient's right eye (od) (b)(6) 2023.The patient experienced an excessive vault.On (b)(6) 2023 the lens was exchanged with the same model and power, shorter length and the problem was resolved.(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: 19660558
• Report Number: 2023826-2024-02779
• Device Sequence Number: 6624095
• Product Code: QCB
• UDI-Device Identifier: 00840311311781
• UDI-Public: 00840311311781
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 06/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 07/03/2024; 07/17/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/03/2024; 07/17/2024
• Date Device Manufactured: 07/18/2023
• 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; MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female