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

Model Number	VTICM13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm13.2; -11.00/2/109 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2022 the patient experienced excessive vaulting and it was noted "iris tinted".Intraoperatively the surgeon removed and replaced the lens with a shorter length lens and this resolved the problem.The cause of the event was reported as a patient related factor and indicated "the lens was too vaulted as he was adjusting to it at that time he chose to go a smaller size and that one fit well.".
Additional Manufacturer Narrative
(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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15080946
• Report Number: 2023826-2022-02372
• Device Sequence Number: 11776103
• Product Code: QCB
• UDI-Device Identifier: 00841542116732
• UDI-Public: 00841542116732
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: VTICM13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2022
• 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#-FCH3701
• Patient Age: 37 YR
• Patient Sex: Female