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

Model Number VTICMO12.6

Device Problems Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Blurred Vision (2137); No Code Available (3191)

Event Date 05/18/2016

Event Type  Injury  

Manufacturer Narrative

The product is manufactured in the us, but not marketed in the us.No similar complaint type events reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -11.0/+3.0/088 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2016.The surgeon reports low vault and refractive change over time.Reportedly, the lens remains implanted.The cause of the event is reported as unknown.

Manufacturer Narrative

Additional information: b5 - it was reported that on 18/03/2020 the lens was exchanged with a longer and different model lens and the problem resolved.Patient was reported to be happy.H6 - patient code 3191: no code available (secondary surgery, lens exchange).Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9532331
• MDR Text Key: 191717666
• Report Number: 2023826-2019-02456
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: VTICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 05/24/2020
• Supplement Dates FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• 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