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

Model Number	VICM5_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
A4-a6:unk.H6: 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 vticmo13.2 implantable collamer lens of a -14.0/3.0/91 (sphere/cylinder/axis) lens was intraoperatively implanted and removed on (b)(6) 2023 due to a lens tear/break during injection/delivery into the patient's left eye (os).On (b)(6) 2023, a replacement lens was implanted and the problem was resolved.There was patient contact and patient injury.Reportedly, "lens got stucked in the plunger." status of the eye is quiet.
Additional Manufacturer Narrative
Additional information: b5: the reporter indicated the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens of diopter -14.0/+3.0/91 (sphere/cylinder/axis) into the left eye (os) 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)(6) 2023 a lens of the same parameters was implanted, and the problem was resolved.The status of the eye as "quiet".H6: health effect- impact code: "4627" should be removed and code "2199" should be added.Claim#: (b)(4).
Additional Manufacturer Narrative
H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Additional Manufacturer Narrative
B5- the reporter indicated that a 13.2mm, vicm5 13.2, -11.5 diopter, implantable collamer lens was implanted into the patient's left eye (os) 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)(6) 2023 a lens of the same parameters was implanted, and the problem was resolved.Claim #: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKICK 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 ; 800 royal oaks dr. suite:210; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 18052033
• Report Number: 2023826-2023-04846
• Device Sequence Number: 7856203
• Product Code: MTA
• UDI-Device Identifier: 00840311300969
• UDI-Public: 00840311300969
• 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,Followup
• Report Date (Section B): 10/24/2023
• 2 Devices were Involved in the Event: 1 2

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: 08/31/2025
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/28/2023; 03/18/2024; 06/18/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/28/2023; 04/23/2024; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male