MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL)

Model Number VTICMO12.6

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

Patient Problems Corneal Clouding/Hazing (1878); Intraocular Pressure Increased (1937); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 11/25/2019

Event Type  malfunction  

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 12.6mm, vticmo12.6, -17.50/2.0/080 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2019 and the patient experienced excessive vault.Corneal haze, aquaport patent, vault 1 1/4 ct, no ic touch and iop=49 was reported on (b)(6) 2019.Patient last visit exam on (b)(6) 2019 found clear cornea, pupil dilate without reflex, vault 2 1/4 ct, no ic touch, iop= 11, ucva 20/30 = 20/20.Lens remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Corrected data: h6- patient code 1937 should be added to the initial mdr.H6- patient code 1878 should be added to the initial mdr.H6- patient code 3191: dilated pupil should be added to the initial mdr.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: IMPLANTABLE COLLAMER LENS (ICL)
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9536340
• MDR Text Key: 191266036
• Report Number: 2023826-2019-02518
• 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
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1