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

Model Number VICMO12.6

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens, -5.0 diopter, into the patient's left eye (os) on (b)(6) 2018.Reportedly, the lens was exchanged on (b)(6) 2018 with a same size, different diopter lens due to refractive surprise.The problem was resolved.

Manufacturer Narrative

Device evaluation: lens was returned dry, in lens case/vial.Visual inspection found the haptic bent.Dimensional and functional inspection found the lens to be within specification.(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 ; 6263037902
• MDR Report Key: 7660091
• MDR Text Key: 113072559
• Report Number: 2023826-2018-00997
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/06/2018

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: 11/30/2020
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2017
• 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: 38 YR