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

Model Number	CC4204A +21.0
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens device evaluation: the lens cartridge was returned loose in the lens box.Visual inspection found clear residue on the product and the lens stuck in the cartridge.Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon made an incision in the patient's left (os) eye in order to implant a cc4204a intraocular lens, diopter +21.0.Reportedly, the surgeon placed the injector into the eye and when he attempted to insert the lens, the lens remained stuck in the injector.The device was then removed from the eye.Date of surgery was (b)(6) 2018.
Additional Manufacturer Narrative
Implanted date: it is corrected from "unk" to "n/a" in the previous supplemental.Implanted date: it is corrected from "unk" to "n/a" in the previous supplemental.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: implanted date: it is corrected from "(b)(6) 2018" to unk.Explanted date: it is corrected from "(b)(6) 2018" to unk.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: 7336767
• Report Number: 2023826-2018-00393
• Device Sequence Number: 16149540
• Product Code: HQL
• UDI-Device Identifier: 00841542102414
• UDI-Public: 00841542102414
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2018

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: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: CC4204A +21.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 04/20/2018; 05/15/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/20/2018; 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR