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

Model Number	CC4204A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.The lens was returned in liquid, in a lens vial.Visual inspection found that the haptic was torn.No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
A cc4204a intraocular lens diopter +21.5 was returned with no reason for the return indicated.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
Corrected data: b4- date of this report 20-mar-2020 is corrected to 05-mar-2020.B5- a cc420a intraocular lens with diopter 21.5 was returned.There has been no complaint against the lens reported.D9- device available for evaluation: 27-feb-2020 is corrected to 25-feb-2020.G4 in inital mdr 20-mar-2020 is corrected to 05-mar-2020.H3- device evaluation: lens returned loose in the box in liquid.Visual observation found no visible damage to lens.H10- lens work order search results are not applicable.Claim# (b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 9960154
• Report Number: 2023826-2020-00851
• Device Sequence Number: 19535212
• Product Code: HQL
• UDI-Device Identifier: 00841542102421
• UDI-Public: 00841542102421
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

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: 02/28/2021
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1