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

Model Number	MICL13.2
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lens returned in liquid, in lens case/vial.Visual inspection found no visible damage to the lens.No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a micl13.2, -4.5 diopter, implantable collamer lens, was implanted upside down in the patients right eye (od).The lens was removed and exchanged with the back up lens during the same surgery.There was no patient injury and it was reported that the cause of the event was unknown.
Additional Manufacturer Narrative
Implanted upside down in the patient's left eye (os).It was reported that the cause of event was surgeon error.(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: 7253425
• Report Number: 2023826-2018-00167
• Device Sequence Number: 110946
• Product Code: MTA
• UDI-Device Identifier: 00841542103183
• UDI-Public: 00841542103183
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR