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

Model Number VICM5_13.2

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

Patient Problems Corneal Edema (1791); Corneal Touch (1794); No Code Available (3191)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Lens work order search: one similar complaint type event reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens, -9.0 diopter, into the patient's right eye (od) on (b)(6) 2017.On (b)(6) 2017 the lens was explanted due to excessive vault.

Manufacturer Narrative

Additional information from surgeon: reportedly, prior to icl removal, the lens was pushing the iris and touching the cornea.The cornea was "starting to get oedematous." device evaluation: the lens was returned in liquid in the lens case/vial.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be within specification.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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: 7156006
• MDR Text Key: 96109583
• Report Number: 2023826-2017-01974
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 12/08/2017

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: 01/31/2019
• Device Model Number: VICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 12/09/2017
• Supplement Dates FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2016
• 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: 44 YR