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

Model Number	MICL12.6
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Lens work order search: no similar complaint type events reported for units within the same lot.Conclusion code: off-label use [over 45 years of age at time of implant ((b)(6))] (b)(4).
Event or Problem Description
Reportedly, a 12.6mm micl12.6, diopter -8.5 implantable collamer lens was implanted into the patient's eye on (b)(6) 2017.It was removed intraoperatively due to the pupil would not constrict as appropriate.On (b)(6) 2018 an alternate lens was successfully implanted.The problem is resolved.
Additional Manufacturer Narrative
Corrected data: reportedly, a 12.6mm micl12.6, -8.5 diopter implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2017.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7267535
• Report Number: 2023826-2018-00208
• Device Sequence Number: 2117240
• Product Code: MTA
• UDI-Device Identifier: 00841542102995
• UDI-Public: 00841542102995
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR