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

Model Number	MICL12.6
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned dry in a cartridge case.Visual inspection found white and clear residue on lens surface and a piece of haptic missing.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a micl12.6, -6.5 diopter, implantable collamer lens in the patient's eye on (b)(6) 2017.During insertion, the lens inverted and rotated.The surgeon had to enlarge the incision to explant the lens.The lens was intraoperatively exchanged with a back-up lens and it was successful.The patient is currently fine.

• 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: 7114231
• Report Number: 2023826-2017-01837
• Device Sequence Number: 1156083
• Product Code: MTA
• UDI-Device Identifier: 00841542102957
• UDI-Public: 00841542102957
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

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: 03/31/2019
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/13/2017
• 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: SFC-45; FOAM TIP PLUNGER; INJECTOR MODEL: MSI-PF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR