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

Model Number	MICL13.7
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation found that the lens was returned in liquid in a lens case/vial and "scratch indent on lens while loading" wriiten on box.Visual inspection found a piece of the haptic missing.No similar complaints types events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon attempted to implant a micl13.7, -11.5 diopter, implantable collamer lens in the patient's eye on (b)(6) 2017.Prior to injection, the surgeon noticed that the lens had a dent.He said that he was unsure if the lens came dented or if it occurred during loading.He did not implant the lens and there was no patient contact or injury.He used a back-up lens and it was successful.

• 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: 7114230
• Report Number: 2023826-2017-01864
• Device Sequence Number: 13936271
• Product Code: MTA
• UDI-Device Identifier: 00841542103596
• UDI-Public: 00841542103596
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

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: 12/31/2018
• Device Model Number: MICL13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1