MAUDE Adverse Event Report: STAAR SURGICAL COMPANY MICL13.2; 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	03/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter stated that the surgeon implanted a micl13.2 implantable collamer lens, -4.5 diopter, in the patient's left eye on (b)(6) 2017.The lens was explanted on (b)(6) 2017 due to excessive vault and shallowing of the acd and exchanged for a smaller lens during the same surgery.There was no reported patient injury or difficulties observed during surgery.Patient's post-op va was 20/25.The reporter stated the cause of the event was unknown.
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid, in a lens vial.Visual inspection found the lens with no visible damage.Claim #(b)(4).

• Brand Name: MICL13.2
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6437168
• Report Number: 2023826-2017-00498
• Device Sequence Number: 759613
• Product Code: MTA
• UDI-Device Identifier: 00841542103183
• UDI-Public: (01)00841542103183(17)180831
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 03/07/2017

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: 08/31/2018
• 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: 03/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2017
• Supplement Report FDA Received Date: 03/27/2017
• 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 - SFC45 - LOT # UNK; INJECTOR MODEL - MSIPF - LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR