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

Model Number MICL13.2

Device Problems Device Operates Differently Than Expected (2913); Scratched Material (3020)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation: lens was returned in liquid, in lens case/vial.Visual inspection found no visible damage to the lens.Work order search: no simliar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon was implanting a micl13.2, -10.0 diopter, implantable collamer lens, in the patients right eye and a scratch was noticed.The lens was removed and the back up lens was used.The reporter stated that there was no patient injury because it was still in the unfolding process so it was only half way into the eye.It was reporter that the event cause was unknown.

Manufacturer Narrative

The reporter indicated that the surgeon was implanting a micl13.2 implantable collamer lens of -10.0 diopter in the patient's right eye (od) on (b)(6) 2017, when he noticed a scratch.The lens was removed and the back-up lens was used.It is uncertain if the lens removal occurred intraoperatively or extraoperatively.The reporter stated that there was no patient injury because it was still in the unfolding process so it was only half way into the eye.It was reported that the event cause was unknown.Explanted date: it is corrected to unk.(b)(4).

Manufacturer Narrative

Explant date: it is corrected from "unk" to "18-dec-2017".(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: 7261525
• MDR Text Key: 99924792
• Report Number: 2023826-2018-00163
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103299
• UDI-Public: 00841542103299
• 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,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2017
• 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: 28 YR