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

Model Number	CQ2015A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Device evaluation: lens was returned in liquid, in lens vial.Visual inspection found half of the optic missing and one haptic was detached from the lens.(b)(4).
Event or Problem Description
The reporter stated that during loading a cq2015a collamer three piece lens, +20.0 diopter, it was noticed that a haptic was damaged.There was no patient contact and the backup lens was implanted.The reporter stated that the cause of the iol damage was received damage.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6447461
• Report Number: 2023826-2017-00479
• Device Sequence Number: 1200320
• Product Code: HQL
• UDI-Device Identifier: 00841542101981
• UDI-Public: (01)00841542101981(17)181031
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2017

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: 10/31/2018
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2017
• Initial Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR