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

Model Number	MICL 13.7
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation; lens was returned in liquid, in a specimen cup.Visual inspection found no visible damage to the lens in liquid.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.7mm micl13.7, -10.5 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2017.On (b)(6) 2018 the lens was removed and exchanged for a shorter length lens due to excessive vault and significant reduction of irido-corneal angles.This exchange resolved the problem.Reporter stated that the cause of this event was patient related factor.

• 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: 7716509
• Report Number: 2023826-2018-01095
• Device Sequence Number: 1107749
• Product Code: MTA
• UDI-Device Identifier: 00841542103572
• UDI-Public: 00841542103572
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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: Health Professional
• Device Expiration Date: 06/30/2018
• 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: 07/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/24/2018
• 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
• Patient Age: 29 YR