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

Model Number	VICM513.2
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Optical Problem (3001); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	12/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that an implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2022.Reportedly, "multiple visual disturbances over the weekend.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Additional information: b5: the reporter indicated that a 13.2mm vicm513.2 implantable collamer lens of a -4.0 diopter was implanted into the patient's right eye (od) on (b)(6) 2022.On (b)(6) 2022, the lens was removed.Reportedly, "severe non-tolerable glare and halos.Cause of the event was a patient related factor.The problem was resolved.Status of the eye is stated as, "glare and halos resolved following explantation." claim# (b)(4).
Additional Manufacturer Narrative
Additional information: originally the claim was determined to be reportable, but upon further review was determined to not meet definition of a complaint.However, the claim cannot be voided as an mdr has already been submitted.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 ; 8002927902
• MDR Report Key: 16091922
• Report Number: 2023826-2023-00045
• Device Sequence Number: 6651552
• Product Code: MTA
• UDI-Device Identifier: 00841542119290
• UDI-Public: 00841542119290
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2022

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: 09/30/2023
• Device Model Number: VICM513.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 02/07/2023; 10/27/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/07/2023; 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2022
• 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: FOAM TIP PLUNGER - LOT# 1585282.; INJECTOR MODEL: LIOLI-24 - LOT# FCJ0702.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female