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

Model Number	MICL13.7
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: lens was returned in a specimen container.Visual inspection found no visible damage to the lens and dry,clear residue on the lens surface.(b)(4).
Event or Problem Description
The reported stated that the surgeon implanted a micl13.7, -10.Diopter, implantable collamer lens in the patient's right eye (od) on (b)(6) 2017.The lens was removed during the same surgery due to the lens size.There was no patient injury.It was reported that the surgeon has been requesting a ubm on each patient with sulcus to sulcus measurement recorded.The white to white reading from the ubm has been running larger than their white to white reading from their digitial caliper.The reporter indicated that the icl chosen was not a mistake on behalf of the online calculator just a conflict in ubm and ditigial caliper measurements and in the future they would like to order the icl size for both measurements to ensure moving forward with any last minute changes that may need to be made.
Additional Manufacturer Narrative
Corrected data: in the initial mdr, "unk" is not applicable the correct date is (b)(6) 2017.In the initial mdr, "unk" is not applicable the correct date is (b)(6) 2018.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENSPHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7239350
• Report Number: 2023826-2018-00162
• Device Sequence Number: 111590
• Product Code: MTA
• UDI-Device Identifier: 00841542103565
• UDI-Public: 00841542103565
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 08/31/2019
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR