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

Model Number	VICM5_12.6
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon inserted and removed a 12.6mm vicm5_12.6 implantable collamer lens, -11.50 diopter, within the same surgery due to the lens was stuck in cartridge or injection system.There was no patient injury.The lens was replaced with a micl12.6 lens and the problem was resolved.
Additional Manufacturer Narrative
Claim # (b)(4).
Additional Manufacturer Narrative
B1 - corrected to adverse event in initial mdr.B2 - corrected to required intervention to prevent impairment/damage (devices) in initial mdr.B5 - "the reporter indicated the surgeon inserted and removed a 12.6mm vicm5_12.6 implantable collamer lens, -11.50 diopter, on (b)(6) 2022 due to the lens was stuck in cartridge or injection system.There was no patient injury.On (b)(6) 2022 at a different surgery the lens was replaced with a vicm5_12.6 lens and the problem was resolved." should be added to the initial mdr.H1 - corrected to serious injury in initial mdr.H6 - medical device problem code: 2993 should be added to the initial mdr.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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15178131
• Report Number: 2023826-2022-02597
• Device Sequence Number: 5072817
• Product Code: MTA
• UDI-Device Identifier: 00841542119214
• UDI-Public: 00841542119214
• 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: 2022
• Device Explanted Year: 2022
• 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): 07/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: VICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2022
• 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 # 1577143.; FOAM TIP PLUNGER MODEL FTP - LOT # 1583636.; INJECTOR MODEL MSI-PF - LOT # 1528353.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female