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

Model Number	VTICMO13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Headache (1880); Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticmo13.2; -16.5/1.0/074 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.The surgeon reports the patient experienced excessive vaulting; significant reduction of irido-corneal angles; angle closure with elevated intraocular pressure; headaches; shallow anterior chamber.On (b)(6) 2023 the lens was explanted.This resolved the problem.The cause of the event was reported as the device and a patient related factor and noted "patient has extreme floppy iris which is causing extreme bowing of iris tissue forwards leading to reduction of iridocorneal angle; left eye worse than right.Iop spikes present causing headache.
Additional Manufacturer Narrative
Health effect clinical code: 4581 - angle closure; significant reduction of irido-corneal angle, shallow anterior chamber.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: h6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16433012
• Report Number: 2023826-2023-00707
• Device Sequence Number: 7521372
• Product Code: QCB
• UDI-Device Identifier: 00840311326754
• UDI-Public: 00840311326754
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: VTICMO13.2
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 03/21/2023; 03/29/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/21/2023; 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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: CARTRIDGE MODEL-SFC-45, LOT#-UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female