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

Model Number VICMO12.6

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

Patient Problems No Information (3190); No Code Available (3191)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vicmo12.6, -8.50 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2017.On (b)(6) 2018 the lens was exchanged for a longer lens due to observation of low vault.This exchange resolved the problem.

Manufacturer Narrative

Additional data: device evaluation: lens was returned dry in a micro-centrifuge vial with clear surgical residue on product.Visual inspection found the haptic torn with foreign material (residue) on lens surface.Corrected data: the reporter indicated that the surgeon implanted a 12.6mm vicmo_12.6 implantable collamer lens (-8.5 diopter) into the patient's right eye (od) on (b)(6) 2017.The lens was explanted due to low vault on (b)(6) 2018.A longer replacement lens was implanted in a later surgery on (b)(6) 2018; problem was resolved.(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
• MDR Report Key: 7857365
• MDR Text Key: 119589234
• Report Number: 2023826-2018-01358
• 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: 08/08/2018

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: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 10/10/2018
• Supplement Dates FDA Received: 10/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2016
• 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: 27 YR