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

Model Number MICL12.6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Iritis (1940); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated that he implanted a 12.6 mm micl12.6, -9.5 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2017.On (b)(6) 2018 the lens was explanted due to chronic iritis.It was reported that the patient was treated with durezol and pred forte for over three months.The reported stated that in his opinion the cause of event was due to patient sulcus anatomy.On (b)(6) 2018 the surgeon reported that the patient is continuing a steroid taper and that the patient continues to recover.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Device evaluation: the lens was returned dry, in a cartridge case.There was residue on product.Visual inspection found foreign material on lens surface (residue on lens) and the lens missing a piece of 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
• MDR Report Key: 7448687
• MDR Text Key: 106133781
• Report Number: 2023826-2018-00586
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103015
• UDI-Public: 00841542103015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

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: 07/31/2019
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 05/07/2018
• Supplement Dates FDA Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• 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: 29 YR