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

Model Number	VTICM5_13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4 - unk.A5 - unk.A6 - unk.H6 - work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2, -10.5/1.0/090 (sphere/cylinder/axis), implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.Significant reduction of iridocorneal angles, glare/haloes, and excessive vault has been observed.Lens remains implanted.Patient remains under observation.Cause of the event is reported as patient related factor.Reportedly, patients anatomy may be abnormal or a measurement error.
Additional Manufacturer Narrative
H6- health effect- clinical code: 4581- significant reduction of iridocorneal angles.B5- the reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens -12.0/+1.5/114 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2023.The patient experienced an excessive vault, significant reduction of iridocorneal angles and glares/haloes.The lens remains implanted, and the problem was not resolved.Status of the eye: "narrow angle, high vault, no other symptoms, monitoring for now".Additional information provided: "would like to request a consultation with an md to discuss the scenario and to receive medical perspective on his plant to observe." the cause of the event is a patient related factor and the device failed to perform as intended.Cause details provided: "high vault os despite accurate preop measurements, patients anatomy may be abnormal; or a measurement error." claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- the reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens -10.50/1.0/090 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) he patient experienced an excessive vault, significant reduction of iridocorneal angles and glares/haloes.The lens remains implanted and the problem was not resolved.Status of the eye: "narrow angle, high vault, no other symptoms, monitoring for now".Additional information provided: "would like to request a consultation with an md to discuss the scenario and to receive medical perspective on his plant to observe." the cause of the event is a patient related factor and the device failed to perform as intended.Cause details provided: "high vault os despite accurate preop measurements, patients anatomy may be abnormal; or a measurement error.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
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia 91016
• MDR Report Key: 16939036
• Report Number: 2023826-2023-01655
• Device Sequence Number: 15316276
• Product Code: QCB
• UDI-Device Identifier: 00841542116640
• UDI-Public: 00841542116640
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2023

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: 03/31/2024
• Device Model Number: VTICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 07/03/2023; 07/11/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 07/03/2023; 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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.
• Patient Age: 30 YR
• Patient Sex: Female