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

Model Number	VTICMO13.2
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
Work order search found no similar complaints.(b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vticmo13.2 implantable collamer lens of -15.00/2.0/102 (sphere/cylinder/axis) was implanted into the patient's eye.Excessive vaulting is observed and a exchange is planned.
Additional Manufacturer Narrative
Corrected data: h1: should be corrected to serious injury.H3 - device evaluation: should be corrected to: the lens was returned in liquid in a specimen cup.Visual inspection found the haptic torn.Dimensional inspection found the lens to be within specifications.Claim#(b)(4).
Additional Manufacturer Narrative
Corrected data: b5: the reporter indicated that a 13.2mm vticmo13.2 implantable collamer lens of -15.00/2.0/102 (sphere/cylinder/axis) was implanted into the patient's eye on an unknown date.Excessive vaulting was observed and the lens was explanted on an unknown date.A shorter lens was used for replacement lens.It is unclear if lens removal and replacement occurred intraoperatively.Additional information: d9: return date: 22/mar/2023.H3 - device evaluation: the lens was returned dry in a microcentrifuge vial.Visual inspection found the haptic torn and broken.Dimensional inspection found the lens to be within specifications.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: 16499868
• Report Number: 2023826-2023-00786
• Device Sequence Number: 14291160
• Product Code: QCB
• UDI-Device Identifier: 00841542120944
• UDI-Public: 00841542120944
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/09/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: VTICMO13.2
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 06/06/2023; 07/10/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 07/05/2023; 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• 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