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

Model Number VICM6 12.6

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cataract (1766)

Event Date 11/28/2023

Event Type  Injury  

Event Description

The reporter indicated that a 12.6mm vicm6 12.6 implantable collamer lens of -12.50 diopter was implanted into the patients right eye (od) on (b)(6) 2022.On (b)(6) 2023 the lens was removed due to lens opacity (cataract).Patient had a cataract surgery with pseudophakic iol implantation.

Manufacturer Narrative

Health effect 4625: patient had a cataract surgery with pseudophakic iol implantation.H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.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 ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18646293
• MDR Text Key: 334592033
• Report Number: 2023826-2024-00474
• Device Sequence Number: 1
• Product Code: MTA
• 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,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2024

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: VICM6 12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2020
• 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