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

Model Number	CC4204A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).
Event or Problem Description
The reporter stated that a cc4204a collamer single piece lens, +22.5 diopter, was implanted and removed within the same surgery because the doctor had to go with a three piece lens due to patients anatomy.There was no patient injury or adverse events.Reporter stated that the cause of the event was not product related.
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid, in lens vial.Visual inspection found a tear on the optic and pieces from the haptic missing.(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: 6601457
• Report Number: 2023826-2017-00896
• Device Sequence Number: 10786979
• Product Code: HQL
• UDI-Device Identifier: 00841542102445
• UDI-Public: (01)00841542102445(17)180930
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2017

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: 09/30/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2017
• Supplement Report FDA Received Date: 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR