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 Code	No Code Available (3191)
Date of Event	03/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: lens was returned dry, in a specimen cup.Visual inspection found no visible damage to the lens and clear surgical residue/debris on product.(b)(4).Work order search: no similar claims were reported for units within the same lot.Claim #(b)(4).
Event or Problem Description
The reporter stated that a micl13.2, -8.0 diopter, implantable collamer lens was explanted because the lens was too big, to be replaced with a 12.6 length lens.There was no reported patient injury.Additional information has been requested but none has been forthcoming.Should additional information be received, a supplemental medwatch report will be submitted.

• 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: 6508247
• Report Number: 2023826-2017-00533
• Device Sequence Number: 885281
• Product Code: MTA
• UDI-Device Identifier: 00841542103251
• UDI-Public: (01)00841542103251(17)181231
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2017

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: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL AND LOT NUMBER - UNK; INJECTOR MODEL AND LOT NUMBER - UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR