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

Model Number	MICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	02/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: lens was returned stuck inside cartridge.Cartridge was returned taped to laf card.Visual inspection found no visible damage to the device, white/grey dry residue was observed on cartridge, and a stuck lens.(b)(4).Work order search: no similar complaints were reported for units within same lot.(b)(4).
Event or Problem Description
The reporter stated that a 13.2mm micl13.2 implantable collamer lens, -16.0 diopter, was implanted on (b)(6) 2017 and explanted on (b)(6) 2017 due to excessive vaulting.The reporter indicated that there was no patient injury and the event was not device related but the exact cause was unknown.

• 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: 6389631
• Report Number: 2023826-2017-00348
• Device Sequence Number: 780295
• Product Code: MTA
• UDI-Device Identifier: 00841542103411
• UDI-Public: (01)00841542103411(17)180731
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2017

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: 07/31/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2017
• Initial Report FDA Received Date: 03/08/2017
• 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: 28 YR