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

Model Number	MICL13.2
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	02/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens was returned dry, in a pouch.Visual inspection found no visible damage to the lens.Clear residue and lent was observed on the lens surface.(b)(4).Secondary surgical intervention, exchange.(b)(4).
Event or Problem Description
The reporter stated that a 13.2mm micl13.2 implantable collamer lens, -11.0 diopter, was explanted due to extreme high pressure.The lens was replaced on (b)(6) 2017 with a shorter length lens.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Work order search: no similar complaints were reported for units within the same lot.(b)(4).
Additional Manufacturer Narrative
Additional information was received.The reporter stated that the patient is doing very well after icl exchange.The lens exchange for a shorter lens resolved the problem.Patient current bscva is 20/20.(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: 6430473
• Report Number: 2023826-2017-00478
• Device Sequence Number: 913303
• Product Code: MTA
• UDI-Device Identifier: 00841542103312
• UDI-Public: (01)00841542103312(17)181130
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2017

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: 11/30/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 05/19/2017; 06/23/2017
• 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: 36 YR