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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4: unk a5: unk a6: unk claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens, -08.50 diopter, into the patients left eye (os) on (b)(6) 2023.The lens was removed later that same day due to excessive vaulting.The lens was replaced with a shorter lens and the problem was resolved.Post-op there was good post-operative appearance and the vault will be monitored.
Additional Manufacturer Narrative
Corrected data: b5: the reporter indicated the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -8.5 into the patient's left eye (os) on (b)(6) 2023.The patient experienced an excessive vault.On the same day the lens was explanted and later replaced with the same model, shorter length was implanted and the problem was resolved.Status of the eye: "good postoperative appearance, monitor vault".The reporter indicated the cause of the event is "other - lens too large for eye".H6: health effect- impact code: "4629" should be removed and code "4627" should be added.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
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17292421
• Report Number: 2023826-2023-02726
• Device Sequence Number: 4109496
• Product Code: MTA
• UDI-Device Identifier: 00841542119382
• UDI-Public: 00841542119382
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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: 10/31/2024
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2022
• 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 # 1631971.; FOAM TIP PLUNGER MODEL FTP - LOT # 1648260.; INJECTOR MODEL AND LOT # UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female