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

Model Number	VTICM5_13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect- clinical code 4581: significant ac shallowing and iris prolapse type of investigation - 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 13.2mm vticm5_13.2 implantable collamer lens of -13.00/3.5/089 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2023.The lens had to be removed at the time of surgery due to noticeably excessive vault intraoperatively with significant ac shallowing and iris prolapse.The lens was removed and surgery was aborted without complication.For status of the eye the reporter stated " normal, no symptoms vision back to baseline".The reporter states the cause of this event is due to the device.The reporter also states that the device failed to perform as intended.
Additional Manufacturer Narrative
Corrected data: b1- "product problem" should be removed and "adverse event" should be added.B2- "other serious or important medical events" should be added.H1- "malfunction" should be removed and "serious injury" should be added.H6- health effect - impact code: "2199" should be removed and "4614" should be added.B5- the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -13.50/3.5/089 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023.The patient experienced an excessive vault, significant ac shallowing, and iris prolapse.Reportedly, "icl had to be explanted at the time of surgery due to noticeably excessive size intraoperatively with significant ac shallowing and iris prolapse.The lens was explanted and surgery aborted without complication".The lens was implanted and removed intraoperatively and the problem was resolved.Status of the eye: "normal, no symptoms vision back to baseline".The cause of the event is the device and the device failed to perform as intended.Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned dry in a specimen cup.Visual inspection found haptic deformed.Dimensional inspection found the lens to be within specifications.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC 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: 17347859
• Report Number: 2023826-2023-02992
• Device Sequence Number: 17645219
• Product Code: QCB
• UDI-Device Identifier: 00841542117111
• UDI-Public: 00841542117111
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: VTICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Female