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 Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned in liquid in a centrifuge vial.Visual inspection of the returned product found no visible damage to the lens.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.7mm micl13.7 implantable collamer lens, -10.0 diopter, in the patient's right eye (od) on (b)(6) 2017.The lens was explanted on (b)(6) 2017 due to excessive vaulting, elevated intraocular pressure (iop), narrowing of the angle, shallowing of the anterior chamber depth (acd) and acute angle closure.The peripheral iridectomies were enhanced.The lens was exchanged with a shorter lens.The patient's post-op uncorrected visual acuity was 20/20 -2 and the patient is happy.The reporter indicated the cause of the event was unknown.
Additional Manufacturer Narrative
The reporter stated the peripheral iridectomies were "tapped/enhanced" due to the elevated intraocular pressure but was unsuccessful.There were additional patient symptoms; patient's vision went "white".The lens exchange was performed on (b)(6) 2017.(b)(4).
Additional Manufacturer Narrative
A lens work order search was performed.No similar complaint type events found.Lens was returned in liquid in a centrifuge vial inside a biohazard bag.(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: 6920137
• Report Number: 2023826-2017-01540
• Device Sequence Number: 819252
• Product Code: MTA
• UDI-Device Identifier: 00841542103565
• UDI-Public: 00841542103565
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2017

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: 02/28/2019
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/06/2017; 12/04/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 10/13/2017; 12/04/2017
• 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 UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL MSI-PF - LOT NUMBER UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR