MAUDE Adverse Event Report: STAAR SURGICAL COMPANY COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE IOL; INTRAOCULAR LENS

Model Number	CC4204A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaints types events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a cc4204a, +23.0 diopter, intraocular lens in the patient's eye on (b)(6) 2017.It was noticed that the lens has lathe marks on it.The lens remains implanted in the eye.There are no patient complications noted.

• Brand Name: COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7131229
• Report Number: 2023826-2017-01900
• Device Sequence Number: 13989557
• Product Code: HQL
• UDI-Device Identifier: 00841542102452
• UDI-Public: 00841542102452
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2017

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: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: CC4204A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 12/19/2017
• Patient Sequence Number: 1
• Patient Age: 71 YR