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

Model Number	MICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pupillary Block (2026); No Code Available (3191)
Date of Event	08/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned dry in a specimen cup.Visual inspection found no visible damage to the lens and clear residue on the lens surface.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a micl13.2, -11.5 diopter, implantable collamer lens in the patient's left eye (os) on (b)(6) 2017.On (b)(6) 2017, the lens was explanted due to excessive vaulting, angle closure, (pupillary block) elevated iop, narrowing of the angle, angle closure, and shallowing of the acd.The lens was then exchanged for another lens.
Additional Manufacturer Narrative
Additional information received.The reporter stated that the software does not always predict correct size implant.The reporter indicated that the surgeon implanted a micl13.2, -11.5 diopter, implantable collamer lens in the patient's left eye (os) on (b)(6) 2017.On (b)(6) 2017, the lens was explanted due excessive vaulting, angle closure, (pupillary block) elevated iop, narrowing of the angle, angle closure, and shallowing of the acd.(b)(4).
Additional Manufacturer Narrative
Method code: no additional similar complaint type event(s) within associated lots were found.The reporter indicated that the surgeon implanted a micl13.2, -11.5 diopter, implantable collamer lens in the patient's left eye (os) on (b)(6) 2017.On (b)(6) 2017, the lens was explanted due to excessive vaulting, angle closure, pupillary block, elevated iop, narrowing of the angle, angle closure, shallowing of the acd and dilated pupil.(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: 6872831
• Report Number: 2023826-2017-01439
• Device Sequence Number: 1364455
• Product Code: MTA
• UDI-Device Identifier: 00841542103329
• UDI-Public: 00841542103329
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2017

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: 01/31/2019
• Device Model Number: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 09/08/2017; 11/02/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 10/05/2017; 11/02/2017
• 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: 26 YR