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

Model Number	MICL12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: the lens was returned dry in a cartridge case.Visual inspection of the returned product found no visible damage to the lens.There was evidence of clear and white residue on the lens.Patient code: (b)(4) - secondary surgical intervention - explant and exchange for same model/length/diopter lens work order search: no similar complaints were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -11.5 diopter, in the patient's left eye (os) on (b)(6) 2017.The lens was explanted on (b)(6) 2017 due to the lens was not positioned correctly in the eye.There was no patient injury.The lens was exchanged with another same model/length/ diopter lens and the problem was resolved.The reporter indicated the cause of the event was unknown but there was no issue with the lens or patient.

• 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: 6595986
• Report Number: 2023826-2017-00838
• Device Sequence Number: 19022673
• Product Code: MTA
• UDI-Device Identifier: 00841542103053
• UDI-Public: (01)00841542103053(17)181231
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2017

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: 12/31/2018
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR