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

Model Number	VICM513.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that surgeon implanted a 13.2mm vicm513.2 implantable collamer lens with a -4.0 diopter, into the patient's left eye (os) on (b)(6) 2022.The lens was later removed and replaced for a shorter length lens due to the lens being too large.Reportedly."did an exchange late last week and the patient is happy.".
Additional Manufacturer Narrative
Weight, ethnicity, race:unk claim# (b)(4).
Additional Manufacturer Narrative
A4-a6:unk.Initial duplicate.Claim# (b)(4).
Event or Problem Description
The reporter indicated that surgeon implanted a 13.2mm vicm513.2 implantable collamer lens with a -5.0 diopter, into the patient's right eye (od) on (b)(6) 2022.The lens was later removed and replaced for a shorter length lens due to the lens being too large.Reportedly."did an exchange late last week and the patient is happy.".
Additional Manufacturer Narrative
B5: lens was implanted and removed on (b)(6) 2022 due excessive vault and significant reduction of iridocorneal angles.Cause of the event is reported as, "low cb-cb lenght." exchanged resolved the problem."status of the eye is reported as, "temporal iris atrophy." h3: device evaluation: lens was not returned with the box.Supp1 - duplicate report for claim (b)(4).Claim# (b)(4).
Additional Manufacturer Narrative
D4 - expiration date: (b)(6) 2023 should be added to the initial mdr.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: 15393063
• Report Number: 2023826-2022-03026
• Device Sequence Number: 6198593
• Product Code: MTA
• UDI-Device Identifier: 00841542119313
• UDI-Public: 00841542119313
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 08/11/2022

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
• Date Returned to Manufacturer: 09/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 09/09/2022; 09/19/2022; 11/16/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 09/09/2022; 10/14/2022; 11/16/2022
• Date Device Manufactured: 06/21/2022
• 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#1577141; FOAM TIP PLUNGER - LOT#1583631; INJECTOR MODEL: MSI-PF LOT# 1545979
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female