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

Model Number	MICL12.6
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned in liquid in lens vial.Visual inspection found one haptic torn.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted a 12.6mm micl12.6 implantable collamer lens, -9.0 diopter , in the patients left eye (os).The surgeon was unable to position the lens properly and was unable to get the lens into the sulcus.This was due to pupillary dilation had become inadequate and was not responding to intraocular meds.The lens was removed and the patient was sent back to the pre-op area for more drops to dilate the pupil.After 45 minutes, this was successful and the patient was brought back to the or.The backup lens was implanted successfully.The patient is happy.The surgeon indicated the cause of the event was due to patient anatomy and iris configuration.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 9747623
• Report Number: 2023826-2020-00317
• Device Sequence Number: 1974775
• Product Code: MTA
• UDI-Device Identifier: 00841542103008
• UDI-Public: 00841542103008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR