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

Model Number	MICL12.6
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	07/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that on (b)(6) 2017 the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, diopter -7.0, into the patient's left (os) eye.On (b)(6) 2017 the lens was exchanged for a shorter and similar diopter lens due to elevated iop.The problem is resolved.
Additional Manufacturer Narrative
Date received by manufactutrer in the intial should be (b)(4) 2017.(b)(4).
Additional Manufacturer Narrative
Date of event: it is corrected to "unk" from "(b)(6) 2017".The reporter stated that the adverse event (elevated iop) was noticed 2-3 weeks before the explant date; (b)(6) 2017.No definite date was provided.(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: 6812325
• Report Number: 2023826-2017-01339
• Device Sequence Number: 13673323
• Product Code: MTA
• UDI-Device Identifier: 00841542102964
• UDI-Public: 00841542102964
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2017

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: 10/31/2018
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 10/06/2017; 10/20/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 10/06/2017; 10/20/2017
• 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
• Patient Age: 24 YR