MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H-10; INTRAOCULAR LENS

Model Number	CQ2015A
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device name: collamer® ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Results code(s): (operational problem): - visual inspection of the returned product found the lens returned inside an mtc-60c fp cartridge.There was no visible damage to the cartridge.Conclusions code(s): (unable to confirm complaint): based on the complaint history and product evaluation, a specific root cause of the event could not be determined.(b)(4).
Event or Problem Description
The reporter stated a cq2015a collamer three piece lens, +19.5 diopter, became stuck inside an mtc-60c fp cartridge.The reporter was unable to provide any additional information.

• Brand Name: SEE H-10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 5807445
• Report Number: 2023826-2016-00952
• Device Sequence Number: 18347
• Product Code: HQL
• UDI-Device Identifier: 00841542101974
• UDI-Public: (01)00841542101974(17)171130
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/20/2016

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: 11/30/2017
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2016
• Initial Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1