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

Model Number	CC4204A
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Lens was returned in liquid, in a lens cas/vial.Visual inspection found a torn haptic.No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
A damage cc4204a ,+18.0 diopter, intraocular lens was returned.A note on the lens packaging box indicated "open & not used, lens tore".Additional information has been requested but non has been forthcoming, if additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected data: correct date for "returned to manufacturer" is 22/05/18.The date 17/05/18 is incorrect.Claim # (b)(4)0.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7626955
• Report Number: 2023826-2018-00928
• Device Sequence Number: 130950
• Product Code: HQL
• UDI-Device Identifier: 00841542102353
• UDI-Public: 00841542102353
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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: 05/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR