MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H10; INTRAOCULAR LENS

Model Number	CC4204A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vitrectomy (2643)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluaion: lens was returned in liquid, in lens vial and biohazard bag.Visual inspection found no damage to the lens.(b)(4).
Event or Problem Description
The reporter stated that a cc4204a collamer single piece lens, +17.5 diopter was used and was being returned due to a unplanned anterior vitrectomy, sutures were required.No iol was implanted after anterior vitrectomy.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
This complaint is corrected to "product problem" from "adverse event".The icl was not implanted in the patient and anterior vitrectomy seems to have been performed due to other patient anatomy issue and before icl implantation.The reporter stated that a cc4204a collamer single piece lens +17.5 diopter was to be used, but was returned instead, due to an unplanned vitrectomy performed on the patient, sutures were required.Type of reportable event is "malfunction" instead of "serious injury." (b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6675859
• Report Number: 2023826-2017-01067
• Device Sequence Number: 19325629
• Product Code: HQL
• UDI-Device Identifier: 00841542102346
• UDI-Public: (01)00841542102346(17)180831
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2017

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: 08/31/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 09/06/2017
• 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: Required Intervention
• Patient Age: 66 YR