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

Model Number	MICL12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -10.0 diopter, in the patient's right eye (od) on (b)(6) 2018.The lens was explanted on (b)(6) 2018 due to excessive vaulting.The lens was exchanged for a shorter lens and the problem was resolved.The reporter indicated the cause of the event was unknown.
Additional Manufacturer Narrative
Device evaluation: the lens was returned dry, in a (b)(4) bag.Visual inspection found a piece of one haptic torn off and missing.There was evidence of clear residue on the lens.(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: 7322043
• Report Number: 2023826-2018-00333
• Device Sequence Number: 119653
• Product Code: MTA
• UDI-Device Identifier: 00841542103022
• UDI-Public: 00841542103022
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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: 08/31/2019
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 04/05/2018
• 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