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

Model Number	MICL13.2
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight, ethnicity, race: unk.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2 mm micl13.2 implantable collamer lens, -13.0 diopter, into the patient's left (os) eye on (b)(6) 2019.The surgeon reports vaulting at 300%, elevated iop, and high risk of angle closure.Lens remains implanted.No additional information has been received.
Additional Manufacturer Narrative
Type of reportable event: malfunction.Claim#: (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: 9186556
• Report Number: 2023826-2019-01905
• Device Sequence Number: 14146976
• Product Code: MTA
• UDI-Device Identifier: 00841542103350
• UDI-Public: 00841542103350
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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: Other
• Patient Age: 20 YR