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); Pain (1994); Pupillary Block (2026); Blurred Vision (2137); No Code Available (3191)
Date of Event	07/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that on (b)(6) 2017 the surgeon implanted a 13.7mm micl13.7 implantable collamer lens, diopter -11.0, into the patient's eye.On (b)(6) 2017 the lens was exchanged for a shorter lens due to excessive vaulting, elevated iop, and angle closure.Attempts to obtain further information have been unsuccessful.
Additional Manufacturer Narrative
Additional symptoms include: iridectomy, blurred vision, pain, pupil block.Lens exchange was performed on the right (od) eye.Device evaluation: lens was returned in liquid in the lens vial.Visual inspection found no visible damage to the lens.(b)(4).
Additional Manufacturer Narrative
Additional information: problem was resolved with lens exchange.(b)(4).
Additional Manufacturer Narrative
Work order search: no similar complaint types were reported for units within the same lot.Previous in mdr follow-up#1: additional symptom: iridectomy._corrected: iridectomy is not a symptom, it was performed prior icl implantation surgery.(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: 6762431
• Report Number: 2023826-2017-01260
• Device Sequence Number: 1490245
• Product Code: MTA
• UDI-Device Identifier: 00841542103589
• UDI-Public: 00841542103589
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/11/2017

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: 09/30/2018
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 08/01/2017; 08/28/2017; 09/21/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 08/22/2017; 09/20/2017; 09/21/2017
• 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: 42 YR