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

Model Number	CC4204A
Medical Device Problem Codes	Device Issue (2379); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2018
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 the lens torn in two pieces and portion of the haptics are missing.No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
A damage cc4204a ,+28.5 diopter, intraocular lens was returned.A note on the lens packaging box indicated "(od) open did not use, 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: (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: 7626855
• Report Number: 2023826-2018-00929
• Device Sequence Number: 1799427
• Product Code: HQL
• UDI-Device Identifier: 00841542102568
• UDI-Public: 00841542102568
• 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: 07/31/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1