MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE D1; INTRAOCULAR LENS

Model Number	CC4204A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.No similar complaint type events reported for units within the same unit.Lens was returned in liquid in lens case/vial.Visual inspection found a torn optic.(b)(4).
Event or Problem Description
The reporter indicated that a cc4204a, +21.5 diopter, intraocular lens had a bad haptic.It was reported that there was no patient injury.Patient contact was reported as n/a.Another staar lens same model was implanted.Reporter was unable to provide additional information.

• Brand Name: SEE D1
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7874815
• Report Number: 2023826-2018-01396
• Device Sequence Number: 228499
• Product Code: HQL
• UDI-Device Identifier: 00841542102421
• UDI-Public: 00841542102421
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

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: 08/31/2019
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR