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

Model Number VTICM5_13.2

Device Problems Misfocusing (1401); No Apparent Adverse Event (3189)

Patient Problems Blurred Vision (2137); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -10.00/+6.0/002 (sphere/cylinder/axis), in the patient's left eye (os), on (b)(6) 2018.The reporter indicated the patient had a corneal astigmatism of 8 diopter.After implantation of the icl the corneal astigmatism reduced to 2 diopter.Therefore the current outcome is plano cylinder -6.00 diopter.The surgeon plans to explant the lens for another lens.The lens to date remains implanted.

Manufacturer Narrative

The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of -10.00/6.0/002 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2018.It was reported the patient experienced refractive surprise due to post-operative reduction in corneal astigmatism from 8 to 2 dioptres.The lens currently remains implanted with explant and new lens implantation planned for the future.Patient code 2692: previous code not applicable.Device code 3189: previous code not applicable.Claim#: (b)(4).

Manufacturer Narrative

The lens was explanted successfully on (b)(6) 2018.The doctor will wait approx.1 month before implanting a new lens.After the explantation the patient is fine.Patient code 3191: secondary surgical intervention, explant.Corrected data: common device name corrected to phakic toric intraocular lens.Claim#: (b)(4).

Manufacturer Narrative

Distributor checked in error.Device evaluation: the lens was returned dry in a lens case/vial.There was clear surgical residue on the lens surface.Visual inspection found that the haptic was bent.Dimensional and functional inspection found the lens to be within specifications.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: 8113436
• MDR Text Key: 129193110
• Report Number: 2023826-2018-01755
• 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: 10/29/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: VTICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 01/22/2019; 02/18/2019; 06/11/2019
• Supplement Dates FDA Received: 01/22/2019; 04/08/2019; 06/18/2019
• 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: 43 YR