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

Model Number VTICMO12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); No Code Available (3191)

Event Date 04/04/2018

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.Device evaluation: the lens was returned dry, in micro-centrifuge vial.Visual inspection found no visible damage to the lens and there was residue on the lens.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -14.00/+3.0/094 (sphere/cylinder/axis), in the patients left eye (os), on (b)(6) 2018.The lens was explanted on (b)(6) 2018 due to patient related factor of vertigo.The vertigo was pre-existing to icl implantation.At one day post-op, the crystalline lens was clear and there was 1+ incisional edema.The vertigo has been reduced and patient will return to c/l wear.The patient elected to have the icl explanted.

Manufacturer Narrative

(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 ; 6263037902
• MDR Report Key: 7555304
• MDR Text Key: 109612290
• Report Number: 2023826-2018-00832
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

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: 08/31/2020
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 08/01/2018
• Supplement Dates FDA Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• 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: 23 YR