MAUDE Adverse Event Report: STAAR SURGICAL COMPANY MICL13.2; PHAKIC INTRAOCULAR LENS

Model Number	MICL13.2
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens was returned dry, in a specimen cup.Visual inspection found no visible damage to lens with debris and clear residue on lens.(b)(4).
Event or Problem Description
The reporter stated that a micl13.2, -7.0 diopter, implantable collamer lens was explanted due to the patient did not like how they felt and did not like having a permanent lens.The lens was explanted a couple of weeks after it was implanted.The reporter stated the lens was not defective and the patient just didn't like them.Additional information was requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

• 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: 6544557
• Report Number: 2023826-2017-00763
• Device Sequence Number: 905388
• Product Code: MTA
• UDI-Device Identifier: 00841542103237
• UDI-Public: (01)00841542103237(17)181130
• 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 Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2017

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: 11/30/2018
• 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: 04/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2017
• Initial Report FDA Received Date: 05/04/2017
• 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