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

Model Number	CC4204A +20.5
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(b)(6) was returned in cartridge.(b)(4).
Event or Problem Description
The reporter indicated that a cc4204a, +20.5 diopter, intraocular lens tore during insertion.There was no patient injury and the backup lens was implanted with no issues.Cause of event was unknown.
Additional Manufacturer Narrative
Corrected data: device evaluation: lens was returned stuck in cartridge.Visual observation found the lens stuck in the cartridge.The nanopoint injector had the lens stuck in the cartridge and clear surgical residue/debris on product.Visual observation found no visible damage to the device and residue on the cartridge.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7857795
• Report Number: 2023826-2018-01351
• Device Sequence Number: 1445766
• Product Code: HQL
• UDI-Device Identifier: 00841542102407
• UDI-Public: 00841542102407
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 08/08/2018

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: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: CC4204A +20.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR