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

Model Number VTICMO12.6

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Glaucoma (1875); Intraocular Pressure Increased (1937); Iritis (1940); Visual Impairment (2138); No Code Available (3191)

Event Date 03/09/2018

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the u.S.No code available (pigment dispersion, secondary surgery, lens explant, fixed pupil) off-label use [over 45 years of age at time of implant (46yrs), anterior endothelium chamber depth < 3.0mm (2.8mm)].(b)(4).

Event Description

The reporter stated that the surgeon implanted a 12.6mm vticmo 12.6, -14.5/+2.5/166 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2018.On (b)(6) 2018 the lens was explanted, reportedly due to pigment dispersion, unreactive (mid-dilated fixed) pupil, and iritis.A yag pi was performed on (b)(6) 2018.The surgeon stated he thought the patient may have had an asymptomatic pupil block due to the viscoelastic used in surgery, but is unable to then explain why it took 2-3 weeks for iritis and pigment dispersion to develop.Attempts to obtain additional information have not been successful.

Manufacturer Narrative

Additional information: after the lens explant, the patient was advised to take pred/gati 3 times daily.After discontinuing, the patient developed an increase in iop and inflammation in the anterior chamber.Currently, the patient is being treated with prednisolone and combigan, azopt, and travatan z for pressure spikes.It is believed that the spikes are due to "steroid use vs inflammatory causes." reportedly, no infection has occurred within the eye.(b)(4).

Manufacturer Narrative

B5-additional information: the patient reports "pressure issues," "blown iris," ongoing glaucoma, and loss of vision.Also stated is that the iris is permanently fixed and dilated.Glaucoma surgery performed.G3-report source added.H6-additional 3191: (blown iris, fixed iris, glaucoma surgery).Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker ave.; monrovia CA 91016
• MDR Report Key: 7419890
• MDR Text Key: 105148946
• Report Number: 2023826-2018-00531
• Device Sequence Number: 1
• Product Code: MTA
• 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: consumer,distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2018

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: Physician
• Device Expiration Date: 09/30/2020
• Device Model Number: VTICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 04/17/2018; 05/11/2020
• Supplement Dates FDA Received: 05/08/2018; 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR