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

Model Number	MICL 13.7
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 13.7mm micl 13.7, -5.5 diopter, implantable collamer lens flipped upside down on insertion into patient's left eye (os) on (b)(6) 2019.There was patient contact (lens touched the eye) with no patient injury.The lens removed and replaced intraoperatively.This resolved the problem.Reportedly, "lens flipped upside down on insertion, with lens 3/4 of the way injected.Lens damaged on removal.".
Additional Manufacturer Narrative
H3-device evaluation: the lens was returned in liquid, in a lens vial.Visual inspection found no visible damage to the lens.Claim#: (b)(4).

• 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: 9565426
• Report Number: 2023826-2020-00008
• Device Sequence Number: 2866662
• Product Code: MTA
• UDI-Device Identifier: 00841542103473
• UDI-Public: 00841542103473
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: MICL 13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 02/26/2020
• 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#SFC-45, LOT#UNK; FOAMTIPPLUNGER MODEL#FTP, LOT#UNK; INJECTOR MODEL#MSI-PF, LOT#UNK
• Patient Age: 25 YR