MAUDE Adverse Event Report: STAAR SURGICAL COMPANY .; PHAKIC TORIC INTRAOCULAR LENS

Model Number	VTICM5_13.2
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	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -07.00/+1.5/100 (sphere/cylinder/axis), into the patients right eye (od) on (b)(6) 2022.The lens had excessive vaulting and remained implanted.Cause of the event was unknown.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Patient weight: unk.Patient ethnicity: unk.Patient race: unk.Explant date: unk.Work order search: no similar complaint was reported for units within the same lot.Claim #: (b)(4).
Additional Manufacturer Narrative
B5: the lens was removed and replaced on (b)(6) 2022.The lens was replaced with a shorter lens and the problem was resolved.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- the reporter indicated the surgeon implanted a 13.2mm vticm5_ 13.2 implantable collamer lens of diopter -07.00/+1.5/100 (sphere/cylinder/axis) into the patients right eye (od) on (b)(6) 2022.On (b)(6) 2022 the lens was explanted due to excessive vault.On the same day separate surgery the lens was replaced with the same model/shorter length lens and the problem was resolved.The status of the eye was reported as "the lens was replaced successfully november (b)(6) 2022" and "vault after one day of surgery 262 micras".The reporter indicated the cause of the event is unknown and the device failed to perform as intended.Reportedly "sizing outlier/ unusual anatomy".Claim# (b)(4).

• Brand Name: .
• 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: 15761749
• Report Number: 2023826-2022-03989
• Device Sequence Number: 8221079
• Product Code: QCB
• UDI-Device Identifier: 00840311311408
• UDI-Public: 00840311311408
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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): 10/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: VTICM5_13.2
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 11/15/2022; 01/03/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/15/2022; 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2022
• 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 # 1581816; FOAM TIP PLUNGER MODEL FTP - LOT # 1577201; INJECTOR MODEL MSI-PF - LOT # 1572651
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female