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

Model Number VICMO12.6

Device Problems Off-Label Use (1494); Patient-Device Incompatibility (2682); Optical Distortion (3000)

Patient Problem Visual Disturbances (2140)

Event Date 01/09/2020

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens diopter -17.5 into the patient's left eye (os) on (b)(6) 2019.On (b)(6) 2022 the lens was exchanged with a same size same diopter lens due to postoperative visual distortion and the problem is resolved.The cause of the event is reported as a patient-related factor.After exchange it is reported that, "self-complaint visual distortion improved slightly.".

Manufacturer Narrative

Weight, ethnicity, and race: unk.This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Claim# (b)(4).

Manufacturer Narrative

"the reporter marked the cause of the event as patient related factor and stated 'the patient has high myopia, posterior scleral stphyloma' as their cause analysis." should be added to the initial mdr.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 13911484
• MDR Text Key: 288022312
• Report Number: 2023826-2022-00962
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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: 03/01/2022

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 Expiration Date: 04/30/2021
• Device Model Number: VICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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 MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female