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

Model Number VICMO12.1

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

Patient Problem No Code Available (3191)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

The product is manufactured in the us, but not marketed in the us.(b)(4).Conclusion code: off-label use [under 21 years of age at time of implant ((b)(6)), anterior endothelium chamber depth < 3.0mm (2.86mm)] (b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.1mm vicmo12.1 implantable collamer lens, diopter -6.0 into the patient's left eye (os) on (b)(6) 2017.On (b)(6) 2017, the lens was exchanged with a longer lens due to low vault.The problem was resolved.

Manufacturer Narrative

Device evaluation: the product was returned dry, in a micro centrifuge vial.Visual inspection found the lens missing a piece of optic and haptic.(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: 7156016
• MDR Text Key: 96109631
• Report Number: 2023826-2017-01978
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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: 10/31/2019
• Device Model Number: VICMO12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• 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: 03/20/2018
• Supplement Dates FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2016
• 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: 18 YR