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

Model Number	MICL12.6
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: returned product evaluation found "two lenses returned in a lens case wrapped with bubble wrap and packing slip." visual inspection found missing piece of haptic.Work order search: no similar complaint type was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated that a micl12.6, -16.0 diopter, implantable collamer lens rotated when it was implanted into the patient's eye.The lens was removed and there was no patient injury.No sutures used and no enlargement of the incision.

• 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: 6583369
• Report Number: 2023826-2017-00865
• Device Sequence Number: 662647
• Product Code: MTA
• UDI-Device Identifier: 00841542103145
• UDI-Public: (01)00841542103145(17)181231
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 05/22/2017
• 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: 33 YR