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

Model Number	CC4204A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Returned product evaluation found lens returned stuck in cartridge.Visual inspection found clear residue on cartridge and no visible damage to device and no visible damage to injector.No similar claim was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated that a cc4204a, +21.0 diopter, collamer single piece intraocular lens got stuck in the cartridge and was not used.There was no patient contact.The reporter was unable to provide further information.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6609865
• Report Number: 2023826-2017-00925
• Device Sequence Number: 225782
• Product Code: HQL
• UDI-Device Identifier: 00841542102414
• UDI-Public: (01)00841542102414(17)181231
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/16/2017

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: 12/31/2018
• Device Model Number: CC4204A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1