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

Model Number	CQ2015A
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer® ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Device evaluation: visual inspection of the returned product found one haptic bent and a piece of the other haptic torn off and missing.The lens was returned dry and there was evidence of clear residue.Work order search: no similar complaints were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated a cq2015a collamer three piece lens, +19.0 diopter, was not used due to had trouble loading the lens.There was no patient contact.The reporter was unable to provide any additional information.
Additional Manufacturer Narrative
Additional information received - the reporter indicated the surgeon loads all the three piece lenses and this lens would not load properly.The proper cartridge and injector were used and another same power three piece lens was used.The collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lenses are generally indicated for primary implantation for the visual correction of (b)(4) in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.Claim # (b)(4).

• 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: 6430431
• Report Number: 2023826-2017-00474
• Device Sequence Number: 539969
• Product Code: HQL
• UDI-Device Identifier: 00841542101967
• UDI-Public: (01)00841542101967(17)180531
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 02/23/2017

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: 05/31/2018
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL AND LOT NUMBER UNK
• Patient Age: 57 YR