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

Model Number VICM513.2

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

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

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

Work order search: no similar complaints within associated lots were found.Claim# (b)(4).

Event Description

The reporter indicated that a 13.2mm vicm513.2 implantable collamer lens of -10.0 diopter was implanted into the patient's left eye (os) on (b)(6) 2023.The lens was intraoperatively implanted and removed due to the initial lens tear/break during injection/delivery into the eye.There was patient contact, but no patient injury.

Manufacturer Narrative

Additional data: b5- the reporter indicated that the surgeon implanted and removed intraoperatively a 13.2mm vicm5 13.2 implantable collamer lens of diopter -10.0 into the patients left eye (os) on (b)(6) 2023.Reportedly the lens tore/broke during injection/delivery into the eye.There was patient contact but no patient injury.On (b)(6) 2023 a replacement lens of the same model/length lens was implanted and the problem was resolved.Status of the eye was reported as "perfect exam".The reporter indicated the cause of the event was user error and the device failed to perform as intended.Reportedly " insufficient viscous?".Claim# (b)(4).

• 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: 16471711
• MDR Text Key: 310588451
• Report Number: 2023826-2023-00721
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 01/31/2023

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
• Device Operator: Health Professional
• Device Model Number: VICM513.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• 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
• Patient Sex: Female