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

Model Number VICMO12.6

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2023

Event Type  Injury  

Manufacturer Narrative

H6 - type of investigation - lens work order search: one similar complaint type event reported for units within the same lot.Claim# (b)(4).

Event Description

The reporter indicated that a 12.6mm vicmo12.6 implantable collamer lens of -5.50 diopter was implanted upside down into the patient's right eye (od) on (b)(6) 2023.On (b)(6) 2023 the lens was explanted with no patient injury and the problem resolved.Cause of event was unknown.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: 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 muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18419662
• MDR Text Key: 331620627
• Report Number: 2023826-2023-05834
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2023

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
• Device Operator: Health Professional
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female