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

Model Number VTICMO13.2

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

Patient Problems Headache (1880); Pain (1994); No Code Available (3191)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Work order search: no similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens, -4.00/+4.0/033 (sphere/cylinder/axis) in the patient's left eye (os), on (b)(6) 2018.The reporter indicated the lens had excessive vaulting and the patient experienced severe headache.The reporter indicated the related symptom may be due to shallow anterior chamber (mid peripheral iridocorneal touch in turn causing headache and eye pain).The lens remains implanted.The reporter stated the cause of the event is the device.

Manufacturer Narrative

The reporter indicated the lens was explanted on (b)(6) 2018.The lens was exchanged for a shorter lens and the problem was resolved.(b)(4).

Manufacturer Narrative

The exchange lens did not resolve the issue.Reference mfr report # 2023826-2019-00435 for further details on the exchange lens.Common device name should be corrected to phakic toric intraocular lens in original mdr.Claim#: (b)(4).

Manufacturer Narrative

Additional data device evaluation- the lens was returned dry in a microcentrifuge vial.Visual inspection found blue residue on lens surface and no visible damage to the lens.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: 8182322
• MDR Text Key: 130974467
• Report Number: 2023826-2018-01885
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/26/2018

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 Expiration Date: 08/31/2021
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 12/24/2018; 02/25/2019; 02/18/2019
• Supplement Dates FDA Received: 01/18/2019; 02/25/2019; 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL SFC-45 - LOT # 1396843; FOAM TIP PLUNGER MODEL FTP - LOT #1398794; INJECTOR MODEL MSI-PF - LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR