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

Model Number	CC4204A
Medical Device Problem Codes	Entrapment of Device (1212); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation found that the lens was returned in liquid in the lens case/vial.Visual inspection found the haptic torn/broken and a piece missing.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon attempted to implant a cc4204a, +19.5 diopter, intraocular lens in the patient's eye on (b)(6) 2017.The surgeon noticed that the lens got stuck and damaged in the inserter, prior to patient contact.A back up lens was then used.
Additional Manufacturer Narrative
Claim #: (b)(4).
Additional Manufacturer Narrative
Work order search: no similar complaint type 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: 6952445
• Report Number: 2023826-2017-01563
• Device Sequence Number: 16314452
• Product Code: HQL
• UDI-Device Identifier: 00841542102384
• UDI-Public: 00841542102384
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2017

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: 10/09/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 11/22/2017; 12/07/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 11/22/2017; 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1