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

Model Number VICM5 12.1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Visual Disturbances (2140)

Event Date 03/14/2024

Event Type  Injury  

Manufacturer Narrative

H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim # (b)(4).

Event Description

The reporter indicated that a 12.1mm vicm5 12.1 implantable collamer lens of -7.00 diopter was implanted into the patient's left eye (os) on (b)(6) 2024.It is alleged that the lens was not the same power as indicated on the label "wrong labeling".On (b)(6) 2024 the lens was explanted and a replacement lens of the same model/size and power was implanted and the problem was resolved.The replacement lens resolved the problem.Cause reported as device.

• 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
• MDR Report Key: 19149713
• MDR Text Key: 340674834
• Report Number: 2023826-2024-01861
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300211
• UDI-Public: 00840311300211
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

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: VICM5 12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2023
• 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: INJECTOR MODEL: MSI-TF, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female