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 Patient Involvement (2645)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens was returned in liquid, in lens case/vial.Visual inspection found half od the lens missing.No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a (b)(4) collamer single piece lens, +21.5 diopter, tore during loading.There was no patient contact.The back up lens was implanted with no problem.The reporter stated that the cause of event was unknown.
Additional Manufacturer Narrative
Corrected data: date of event (b)(6) 2017 is incorrect, should be unknown.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: 7229592
• Report Number: 2023826-2018-00154
• Device Sequence Number: 1222481
• Product Code: HQL
• UDI-Device Identifier: 00841542102421
• UDI-Public: 00841542102421
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/04/2018

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: 08/31/2019
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 03/26/2018; 04/11/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 03/26/2018; 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR