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

Model Number VICMO13.2

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)

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

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

H6 - device code: 1494 - this lens model is contraindicated for patients with an anterior chamber depth (acd) less than 3.0mm.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vicmo13.2 implantable collamer lens, -15.00 diopter, in the patients right eye (od), on (b)(6) 2023.The lens was explanted on (b)(6) 2023, due to excessive vaulting.The lens was replaced with a shorter lens and the problem was resolved.The cause of the event was unknown.

• 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: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18820160
• MDR Text Key: 336735785
• Report Number: 2023826-2024-00956
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VICMO13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2023
• 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 # 1677784; FOAM TIP PLUNGER MODEL FTP - LOT # 1662682; INJECTOR MODEL MSI-PF - LOT # 1449235
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male