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

Model Number VICM5_12.6

Device Problems Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)

Patient Problems Blurred Vision (2137); No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Exact date of event is unknown; (b)(6) 2018 is reported.Product manufactured but not sold in the u.S.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens, -9.5 diopter into the patient's right eye (od) on (b)(6) 2016.The surgeon reports mild refractive error (myopia, astigmatism) and white foreign matter adhered to the surface of the lens, which has increased from the first exam to the follow-up exam.The cause of the event is listed as unknown.Reportedly, the patient is undergoing steroid treatment and is under follow-up.The lens remains implanted.

Manufacturer Narrative

No similar complaint type events were reported for units within the same lot.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 7639952
• MDR Text Key: 112408636
• Report Number: 2023826-2018-00966
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

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: 07/31/2019
• Device Model Number: VICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 09/14/2018
• Supplement Dates FDA Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR