MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H10; 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	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluation: the lens was returned dry in the lens case/vial.Visual inspection found the haptic bent and missing a piece.Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that, as the surgeon was implanting a cc4204a intraocular lens, diopter +24.5, into the patient's left (os) eye, the lens tore.Intra-operatively, the lens was successfully removed and replaced with an alternate lens.The date of surgery was (b)(6) 2018.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7336754
• Report Number: 2023826-2018-00391
• Device Sequence Number: 10925271
• Product Code: HQL
• UDI-Device Identifier: 00841542102483
• UDI-Public: 00841542102483
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

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: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR