MAUDE Adverse Event Report: STAAR SURGICAL COMPANY COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE IOL; INTRAOCULAR LENS

Model Number	CC4204A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned in cartridge and loose in lens box.Visual inspection of the delivery system found the lens caught in loading chamber.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon attempted to implant a cc4204a, 23.0 diopter, intraocular lens in the patient's eye on (b)(6) 2017.The lens got stuck in the cartridge, so a back up lens was used.There was no patient contact with the first lens.
Additional Manufacturer Narrative
Work order search: no similar complaints types events were reported for units within the same lot.Claim #: (b)(4).

• Brand Name: COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6952433
• Report Number: 2023826-2017-01569
• Device Sequence Number: 1209205
• Product Code: HQL
• UDI-Device Identifier: 00841542102452
• UDI-Public: 00841542102452
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/20/2017

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: 12/31/2018
• Device Model Number: CC4204A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1