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

Model Number VICM5_13.2

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Intraocular Pressure Increased (1937); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2022

Event Type  Injury  

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2; -13.0 diopter implantable collamer lens into the patient's right eye (od) on (b)(6) 2022.The patient experienced excessive vaulting.On (b)(6) 2022 the lens was explanted and later on this same date a replacement lens of shorter length was implanted and this resolved the problem.The cause of the event was reported as "bigger lens".

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.Claim #: (b)(4).

Manufacturer Narrative

B5 - patient experienced pain and elevated intraocular pressure - should have been included in initial medwatch report.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: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14138530
• MDR Text Key: 289512150
• Report Number: 2023826-2022-01231
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 03/21/2022

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 Model Number: VICM5_13.2
• 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: 03/21/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 05/27/2022
• Supplement Dates FDA Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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: 27 YR
• Patient Sex: Female