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

Model Number VICM512.6

Device Problems Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

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

Event Date 08/28/2023

Event Type  malfunction  

Event Description

The reporter indicated that 12.6mm vicm512.6 implantable collamer lens of a -7.0 diopter tore/broke during injection into the patient's right eye (od) on (b)(6) 2023.There was patient contact, but no patient injury.Cause of the event was user error, with the device failing to perform.Reportedly, "the lens foot plate was missing and likely it was caught on the cartridge and was only noticed when it was in the eye already." a replacement lens was implanted and the problem was resolved.

Manufacturer Narrative

A4-a6:unk.H6: user error.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 muniz ; 800 royal oaks suite:210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17741570
• MDR Text Key: 323404603
• Report Number: 2023826-2023-03992
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542119122
• UDI-Public: 00841542119122
• 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: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VICM512.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2023
• 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 - LOT#UNK.; FOAM TIP PLUNGER - LOT# UNK.; INJECTOR MODEL: LIOLI-24 - LOT# FCK2004.
• Patient Age: 26 YR
• Patient Sex: Female