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

Model Number VICMO13.2

Device Problem Misfocusing (1401)

Patient Problems Dry Eye(s) (1814); Headache (1880); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); No Code Available (3191)

Event Date 11/12/2015

Event Type  Injury  

Manufacturer Narrative

Product is manufactured but not sold in the u.S.(b)(4).

Event Description

The reporter indicated that the surgeon implanted an implantable collamer lens, -13.0 diopter into the patient's leftt eye (os) in (b)(6) of 2015.Hypermetropia of +1, astigmatism of "around" 0.5, pain, and red eye is reported.Lasik surgery was performed (b)(6) 2017 which resolved the problem.However, red eye still occurs approximately every 2 months.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

"headache, dry eye and nausea is reported." should be added to the initial mdr.Patient code 3191: nausea.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8774155
• MDR Text Key: 150518381
• Report Number: 2023826-2019-01205
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 06/18/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: VICMO13.2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 07/25/2019; 10/14/2019
• Supplement Dates FDA Received: 08/20/2019; 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR