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

Model Number	VICM513.7
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information:unk.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.7mm vicm513.7,implantable collamer lens with a -7.0 diopter was implanted into the patient's right (od) eye on (b)(6) 2022.The lens was implanted, removed, and replaced for a shorter length lens.
Additional Manufacturer Narrative
B5: lens was replaced due to excessive vaulting.Problem was resolved.Cause of the event is reported as "user error." the device did not fail to perform as intended.Reportedly, "good vault, corenal edema is resolving.Patient is on track and progressing well.Icls are well positioned." claim#: (b)(4).
Additional Manufacturer Narrative
(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: 15375453
• Report Number: 2023826-2022-03028
• Device Sequence Number: 5674204
• Product Code: MTA
• UDI-Device Identifier: 00841542119580
• UDI-Public: 00841542119580
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 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: VICM513.7
• 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: 08/11/2022
• Supplement Date Received by Manufacturer: 11/14/2022; 11/30/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 11/28/2022; 11/30/2022
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown