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

Model Number	CC4204A
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Lens was returned in liquid, in lens vial.Visual inspection found tears on footplate.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted and removed a cc4204a, +20.5 diopter, implantable collamer lens because the incision was not big enough and the lens was scratched during injection.The reporter stated that the scratch was noticed after implantation but that the lens could have been scratched and just not noticed.The lens was removed within the same surgery and the back-up lens was implanted.The incision was enlarged to remove the lens, no suture needed.There was no patient injury.
Additional Manufacturer Narrative
The reporter indicated that the surgeon implanted and removed a cc4204a intraocular lens of +20.5 diopter as the incision was not big enough and the lens could have been scratched during injection.The reporter stated that the scratch was noticed after implantation but that the lens could have been scratched and just not noticed.The lens was removed within the same surgery.A back-up lens was implanted.The incision was enlarged to remove the lens, no suture needed.There was no patient injury.(b)(4).Method: no additional similar complaint type events were found within the associated lot.(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: 7119107
• Report Number: 2023826-2017-01884
• Device Sequence Number: 11045469
• Product Code: HQL
• UDI-Device Identifier: 00841542102407
• UDI-Public: 00841542102407
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/17/2017

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: 02/28/2019
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 02/07/2018
• 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