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

Model Number	VICM5_13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that a 13.2mm vicm5_13.2, -04.50 diopter, implantable collamer lens was implanted, removed, and replaced with a same length different power lens intraoperatively on (b)(6) 2023 from patient's left eye (os) due to wrong lens power being implanted.This resolved the problem.Cause of the event is reported as other, root cause to be determined.
Additional Manufacturer Narrative
Claim# (b)(4).
Additional Manufacturer Narrative
Additonal data: b5- the reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -4.50 into the left eye (os) on (b)(6) 2023.Reportedly "incorrect icl implanted".The lens was implanted, removed and replaced intraoperatively with a different model/shorter length lens and the problem was resolved.Status of the eye: "no further aes resulted from the lens exchange, subject has completed study".The reporter indicated that the cause of the event is "other" and the device did not fail to perform as intended.Cause details: "site failed to enforce proper time-out steps to ensure confirmation of subject identifying information before proceeding (i.E., name, date of birth etc.) thus a lens for another subject was implanted.The error was discovered 30 minutes later and after obtaining verbal consent the lens exchange was performed".Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- originally the claim was determined to be reportable, but upon further review was determined to not meet definition of a complaint.However, the claim cannot be voided as an mdr has already been submitted.The event was procedure related and not due to the device.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: 17279035
• Report Number: 2023826-2023-02621
• Device Sequence Number: 3555468
• Product Code: MTA
• UDI-Device Identifier: 00841542119306
• UDI-Public: 00841542119306
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 08/22/2023; 08/29/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 08/23/2023; 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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
• Patient Age: 36 YR
• Patient Sex: Female