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

Model Number	VICM5_13.2
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Cataract (1766)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm micl13.2; -5.50 diopter implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.The surgeon reports low vaulting without rotation and lens cataract (cortical observed on (b)(6) 2023).Lens remains implanted.Problem is not resolved.It was additionally noted "good.No complaints per patient".If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected data: b5: the reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -5.50 into the patient's left eye (os) on (b)(6) 2023.The patient experienced low vault and cortical lens opacity was observed on (b)(6) 2023.The lens remains implanted.The problem was not resolved.Status of the eye: "good.No complaints per pt.".The reporter indicated the cause of the event is unknown.H6- medical device problem code: "1494- off label use (keratoconus)" should be added.H6- medical device problem code: "4614" should be removed and "2199" 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16891772
• Report Number: 2023826-2023-01749
• Device Sequence Number: 6326446
• Product Code: MTA
• UDI-Device Identifier: 00841542119320
• UDI-Public: 00841542119320
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

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: 08/31/2024
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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: INJECTOR MODEL-LIOLI-24, LOT#-UNK.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Female