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

Model Number VICMO12.6

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  Injury  

Manufacturer Narrative

Claim# (b)(4).

Event Description

The reporter indicated that the surgeon had trouble inserting a 12.6mm vicmo12.6 implantable collamer lens of -16 diopter.The suregon admits to error and not rotating his hand when the lens came out sideways.He aborted the implantaton and implanted the backup lens.

• 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 enriquez ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 15547034
• MDR Text Key: 301232838
• Report Number: 2023826-2022-03450
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542122047
• UDI-Public: 00841542122047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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
• Patient Outcome(s): Required Intervention