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

Model Number	MICL13.2
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Scratched Material (3020)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	12/18/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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).
Additional Manufacturer Narrative
Explant date: it is corrected from "unk" to "18-dec-2017".(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7261525
• Report Number: 2023826-2018-00163
• Device Sequence Number: 763804
• Product Code: MTA
• UDI-Device Identifier: 00841542103299
• UDI-Public: 00841542103299
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2018

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?: Yes
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 03/22/2018; 04/11/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 03/29/2018; 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR