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

Model Number	VICM5_13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2; -13.50 diopter implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.The patient experienced excessive vaulting.The surgeon repositioned the lens on (b)(6) 2023 and this resolved the problem.It was additionally noted "the doctor rotated the lens 90 degrees vault is ok".The cause of the event was reported as unknown.
Additional Manufacturer Narrative
Additional data: h6: health effect - clinical code: "4581- unreactive (fixed) pupil" should be added.B5: the reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -13.50 into the patients right eye (od) on (b)(6) 2023.The patient experienced an excessive vault.On (b)(6) 2023, the lens was repositioned.It was later reported the patient also experienced an unreactive (fixed) pupil.The lens remains implanted and the problem was not resolved.Status of the eye: "the pupil does not close completely".Additional information provided: "the supposed high vault was reduced by a rotation.The case has been updated.I dont have a number yet".Reportedly "the doctor has not yet decided how to proceed with the patient." the cause of the event is user error and the device did not fail to perform as intended.Cause details: " the doctor used hyaluronic acid".Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information: b5- the problem was resolved.Status of the eye: "the pupil closes better".Additional information provided: "there are currently no measures planned.The patient is happy." claim# (b)(4).

• 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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17131350
• Report Number: 2023826-2023-02394
• Device Sequence Number: 18000725
• Product Code: MTA
• UDI-Device Identifier: 00840311301003
• UDI-Public: 00840311301003
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2023

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: 10/31/2025
• Device Model Number: VICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 07/27/2023; 11/06/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 08/16/2023; 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• 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 MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female