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

Model Number	CC4204A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt info: unk.Concomitant medical product: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.No similar complaint type events were reported for units within the same lot.Lens was returned stuck in cartridge.Visual inspection found lens stuck in cartridge.Cartridge returned with lens stuck in cartridge.Visual inspection found lens stuck in cartridge.(b)(4).
Event or Problem Description
The reporter indicated that the cc4204a, +23.5 diopter, intraocular lens loaded but would not advance in cartridge.It was reported that there was no patient contact.It was reported that there was a loading error that could have been caused by training a new scrub nurse, but there is no certainty to the cause of the event.Backup lens was inserted without any reported problems.Patient is doing fine.
Additional Manufacturer Narrative
(b)(4).Claim#: (b)(4).
Additional Manufacturer Narrative
Claim#: (b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8159569
• Report Number: 2023826-2018-01835
• Device Sequence Number: 11292678
• Product Code: HQL
• UDI-Device Identifier: 00841542102469
• UDI-Public: 00841542102469
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2018

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: Health Professional
• Device Expiration Date: 02/29/2020
• 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: 12/06/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 02/11/2019; 02/18/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 02/11/2019; 02/19/2019
• 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: INJ SYSTEM-NANOPOINT INJECTION SYSTEM, LOT#-UNK; INJECTOR#MSI-NP,LOT#UNK