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

Model Number	VICM5_13.7
Medical Device Problem Codes	Off-Label Use (1494); 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	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Health effect clinical code: 4581 - shallow ac; significant reduction of irido-corneal angles.Medical device problem code - 1494: off-label use (over 45 yrs of age at date of implant).(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.7mm vicm5_13.7; -3.5 diopter implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.The surgeon reports the patient has excessive vaulting and significant reduction of irido-corneal angles and shallow ac.The surgeon notes they likely will replace the icl with a smaller lens; either 13.2 or 12.7.Lens remains implanted.The cause of the event was reported as the device and indicated "vault in the right eye is causing a definite shallowing of ac and will likely need to be removed next week".If additional information is received a supplemental medwatch report will be submitted.

• 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: 16587801
• Report Number: 2023826-2023-01007
• Device Sequence Number: 6067804
• Product Code: MTA
• UDI-Device Identifier: 00841542119511
• UDI-Public: 00841542119511
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2023

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: 08/31/2024
• Device Model Number: VICM5_13.7
• 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: 02/24/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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
• Patient Age: 50 YR
• Patient Sex: Male