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

Model Number	MICL13.7
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Nausea (1970); Pain (1994); No Code Available (3191)
Date of Event	08/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter stated the surgeon implanted a 13.7mm micl13.7 implantable collamer lens, -10.5 diopter, in the patient's right eye (od) on (b)(6) 2017.The patient returned the next day, (b)(6) 2017, in pain, nauseous, with a pressure spike (60mmhg) and steamy eye.Another iridotomy was performed and pressure dropped down to 40mmhg.The chamber was shallow, with some angle closure and the surgeon decided to explant the lens the same day.A shorter lens (13.2mm) was implanted but the pressure again spiked and the lens was explanted same day ((b)(6) 2017) - see mdr #2023826-2017-01383.A third lens was not implanted.The lens was discarded.The patient is doing fine.
Additional Manufacturer Narrative
(b)(4).Device manufacturer date: it is corrected to 23-dec-2016.(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: 6832459
• Report Number: 2023826-2017-01382
• Device Sequence Number: 1419950
• Product Code: MTA
• UDI-Device Identifier: 00841542103572
• UDI-Public: 00841542103572
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2017

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: 11/30/2018
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 10/16/2017
• 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: 31 YR