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

Model Number	MICL13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Intraocular Pressure Increased (1937); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter stated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -10.0 diopter, in the patient's right eye (od), on (b)(6) 2017.The lens was explanted on (b)(6) 2017 due to elevated intraocular pressure and pigment dispersion.The patient experienced additional symptoms - headache.The lens was not exchanged for another lens.The patient's current condition post-op - bscva - 20/30, intraocular pressure - 18mm hg.The reporter indicated the cause of the event was due to pigment dispersion/anatomical anomaly (abnormal sulcus anatomy).The patient has planned therapy of laser vision correction (lvc).
Additional Manufacturer Narrative
Lens was returned in lens case.Visual inspection found haptic deformed.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: 6853814
• Report Number: 2023826-2017-01415
• Device Sequence Number: 1430930
• Product Code: MTA
• UDI-Device Identifier: 00841542103299
• UDI-Public: 00841542103299
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2017

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: 01/31/2019
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 09/20/2017
• 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