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

Model Number	MICL13.7
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): secondary surgical intervention, lens explanted and exchanged for shorter lens.Work order search: no similar complaints were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.7mm micl13.7 implantable collamer lens, -11.5 diopter, in the patient's left eye (os) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to excessive vaulting, narrowing of the angle and shallowing of the anterior chamber.The lens was exchanged for a shorter lens.The reporter indicated a probable cause of the event was inaccurate white-to-white measurement.The patients post-op bscva was 20/20.The lens was discarded by the facility.
Additional Manufacturer Narrative
Additional information received.The reporter indicated the patient post-op was experiencing glare/halo issues.The patient was medically treated with alphagan, which failed to help the patient.The patient was then treated with pilocarpine 1%, which had a miotic effect.(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: 6521050
• Report Number: 2023826-2017-00694
• Device Sequence Number: 13785764
• Product Code: MTA
• UDI-Device Identifier: 00841542103596
• UDI-Public: (01)00841542103596(17)170731
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2017

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: 07/31/2017
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL SFC-45 FP - LOT NUMBER 1330931; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER 1348634; INJECTOR MODEL MSI-PF - LOT NUMBER 1366934
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 86