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

Model Number	CC4204A +21.0
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Word order search: no similar complaint type events were reported for units within the same lot.Device evaluation: lens was returned in vial, in liquid.Visual inspection found haptic torn.Patient code: (b)(4) secondary surgical intervention, explant.(b)(4).
Event or Problem Description
The reporter indicated of a cc4204a, +21.0 diopter, intraocular lens to be irregular.It was reported that there was patient contact but no paitent injury.The reporter was unable to provide additional information on the event.
Additional Manufacturer Narrative
Lens was returned in liquid in vial.Visual inspection found haptic torn; torn haptic piece missing.(b)(4).
Additional Manufacturer Narrative
(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: 7825098
• Report Number: 2023826-2018-01294
• Device Sequence Number: 13830570
• Product Code: HQL
• UDI-Device Identifier: 00841542102414
• UDI-Public: 00841542102414
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 08/31/2018
• Device Model Number: CC4204A +21.0
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 10/19/2018; 11/01/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 10/31/2018; 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention