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

Model Number	VTICM5_13.2
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Halo (2227)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2; -7.0/1.50/83 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6) 2022.On (b)(6) 2022 the lens was explanted due to halos.The cause of the event was reported as unknown.The problem was reported as resolved and not resolved; it was indicated the lens was removed due to the patient's wish; refractive outcome ua unchanged to pre-op.Patient is considering laser refractive surgery in one year.
Additional Manufacturer Narrative
H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim#: (b)(4).
Additional Manufacturer Narrative
H3: device evaluation - lens was returned in microcentrifuge vial dry.Visual inspection found no visible damage to lens.Dimensional inspection found the lens to be within specification.Functional inspection found that the returned lens did not meet original values measured at the time of manufacturing.H6: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device; have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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 CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16250870
• Report Number: 2023826-2023-00339
• Device Sequence Number: 20484510
• Product Code: QCB
• UDI-Device Identifier: 00840311311408
• UDI-Public: 00840311311408
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2023

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: 07/31/2025
• Device Model Number: VTICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 01/05/2023
• Supplement Date Received by Manufacturer: 06/07/2023; 08/22/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 06/08/2023; 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Male