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

Model Number	CC4204A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluation: the lens was returned in liquid, in lens vial.Visual inspection found the optic, haptic torn, and pieces missing from the haptic.Work order search: no similar complaints were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated the surgeon attempted to insert a cc4204a collamer single piece lens, +23.0 diopter, but noted the lens was torn.There was patient contact but no injury.The reporter stated that lens most likely tore during the loading process and was due to a loading error.The backup lens was implanted.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6404846
• Report Number: 2023826-2017-00404
• Device Sequence Number: 13686105
• Product Code: HQL
• UDI-Device Identifier: 00841542102452
• UDI-Public: (01)00841542102452(17)180228
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/21/2017

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: 02/28/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2017
• Initial Report FDA Received Date: 03/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1