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

Model Number	MICL 12.6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2019
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 the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -13.0 diopter, into the patient's right eye (od) on (b)(6) 2019.During insertion, the lens flipped in the eye, "as inserted the lens appeared to flip." intraoperatively, the lens was successfully exchanged with an alternate lens.Reportedly, no patient injury occurred.Cause of the event is reported as unknown.
Additional Manufacturer Narrative
Product evaluation: lens was returned in liquid in a lens vial.Visual inspection found no visible damage to the lens.(b)(4).
Additional Manufacturer Narrative
Correction: "intraoperatively, the lens was successfully exchanged." in initial mdr should be changed to "the lens was successfully exchanged on the same day.However, it is unknown if the exchange occurred during the inital surgery." (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: 8798403
• Report Number: 2023826-2019-01108
• Device Sequence Number: 311515
• Product Code: MTA
• UDI-Device Identifier: 00841542103084
• UDI-Public: 00841542103084
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2019

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: 10/31/2019
• Device Model Number: MICL 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/23/2019; 09/05/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/21/2019; 09/05/2019
• 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#1438423; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-TF,LOT#UNK; CARTRIDGE MODEL#SFC-45,LOT#1438423; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-TF,LOT#UNK
• Patient Age: 40 YR