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

Model Number	VTICM512.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of a -13.0/1.0/091 (sphere/cylinder/axis) was torn when the surgeon delievered it into the patient's right eye (od) with the lioli injector.The lens was removed.
Additional Manufacturer Narrative
Patient identifier, age or date of birth, sex, weight, ethnicity, race:unk.Work order search found no similar complaints within associated lots.Claim #(b)(4) 1d complaint not similar to this complaint.Claim# (b)(4).
Additional Manufacturer Narrative
B5: the reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of a -13.0/1.0/091 (sphere/cylinder/axis) was implanted upside down.Patient contact but no patient injury.Lens was implanted, removed and replaced intraoperatively on (b)(6) 2022 and problem was resolved.Cause of event was reported as "user error".The device did not fail to perform."surgeon implant error" was reported.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 15697669
• Report Number: 2023826-2022-03888
• Device Sequence Number: 20509837
• Product Code: QCB
• UDI-Device Identifier: 00841542115384
• UDI-Public: 00841542115384
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 12/29/2022

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: 03/31/2024
• Device Model Number: VTICM512.6
• 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: 10/03/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 10/30/2022
• Supplement Report FDA Received Date: 01/03/2023
• Date Device Manufactured: 05/03/2022
• 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 Age: 29 YR
• Patient Sex: Female