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

Model Number VTICMO13.7

Device Problems Misfocusing (1401); Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

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

Event Date 05/30/2019

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.No similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that a vticmo13.7, -15.50/4.0/085 (sphere/cylinder/axis), implantable collamer lens was "cut at the end of the insertion" into patients right eye (od) on (b)(6) 2019.The reporter indicated the cause of the cut was due to the lens being "stuck to foam tip." the lens remains implanted, "as part of it was cut hence the diameter of lens was smaller and the lens dislocated." reporter indicated the "icl is in a vertical position" and patient's "vision is poor due to astigmatism." the reporter indicated no patient injury and plans to exchange the lens.

Manufacturer Narrative

Device evaluation: lens was returned in liquid in a lens case/vial.Visual inspection found the haptic torn.Claim#: (b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

"the lens remains implanted" should be corrected to "the lens was removed and replaced on (b)(6) 2019" in the initial mdr."plans to exchange the lens" should be removed in the initial mdr.Patient code 3191- secondary surgical intervention, explant.

• 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: 8741157
• MDR Text Key: 149499309
• Report Number: 2023826-2019-01132
• 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,Followup,Followup
• Report Date: 06/03/2019

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: 07/31/2021
• Device Model Number: VTICMO13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/27/2019
• Supplement Dates Manufacturer Received: 08/29/2019; 08/29/2019; 09/18/2019
• Supplement Dates FDA Received: 08/29/2019; 08/29/2019; 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL#SFC-45,LOT#1431730; FOAMTIPPLUNGER MODEL#FTP,LOT#1426991; INJECTOR MODEL#MSI-TF,LOT#UNK
• Patient Outcome(s): Required Intervention