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	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	12/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens remains implanted.Planned explant date is undetermined.Work order search: no similar claims were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated that a micl12.6, -9.0 diopter, implantable collamer lens was implanted on (b)(6) 2016.On (b)(6) 2016 the patient reported experiencing glares and halos.The lens currently remains implanted but the doctor is planning to explant the lens.The patient's next visit is scheduled on (b)(6) 2017 and the doctor will schedule the surgery date to explant the lens.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The initial lens was implanted in the patient's right eye (od).The lens was explanted on (b)(6) 2017.The patient's post-op indicates that the patient has intractable peripheral glare in spite of excellent icl placement and is unable to drive at night.H3-device evaluation: the lens specimen was returned in a specimen cup and there was some moisture on the lens.Visual inspection found the haptic torn and a piece of haptic missing.(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: 6624647
• Report Number: 2023826-2017-00912
• Device Sequence Number: 746824
• Product Code: MTA
• UDI-Device Identifier: 00841542102346
• UDI-Public: (01)00841542102346(17)181231
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2017

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: 04/30/2018
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 09/14/2017
• 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: Other; Required Intervention
• Patient Age: 40 YR