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

Model Number	MICL12.1
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted an micl12.1, -9.5 diopter, implantable collamer lens in the patient's right eye (od) on (b)(6) 2017.Refractive surprise was noticed as the patient is now approximately +1.25d seq post-op.The surgeon confirmed that the icl is sitting in the correct position and not inverted.He also verified that the cyclo was not significantly different that the manifest refraction.Attempts at obtaining additional information have been unsuccessful.
Additional Manufacturer Narrative
Method: no similar complaints were reported for units within the same lot.(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: 6839063
• Report Number: 2023826-2017-01374
• Device Sequence Number: 13643601
• Product Code: MTA
• UDI-Device Identifier: 00841542102742
• UDI-Public: 00841542102742
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: MICL12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 10/12/2017
• 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: Other