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

Model Number	CC4204A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluation: lens was returned in vial, in a biohazard bag.Visual inspection found the lens torn in four pieces.(b)(4).
Event or Problem Description
The reporter indicated that a cc4204a, +18.0 diopter, intraocular lens was implanted into the patient's left eye (os) on (b)(6) 2018.On (b)(6) 2018 the lens was removed due to mispowered iol, wrong power for eye.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Eye, cannot verify it was the patient's left eye (os).(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: 7664583
• Report Number: 2023826-2018-01004
• Device Sequence Number: 2365062
• Product Code: HQL
• UDI-Device Identifier: 00841542102353
• UDI-Public: 00841542102353
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 08/16/2018
• 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
• Patient Age: 73 YR