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 Codes	Capsular Bag Tear (2639); No Code Available (3191)
Date of Event	07/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned in liquid in the lens vial.Visual inspection found the lens torn in three pieces.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a cc4204a, +19.0 diopter, intraocular lens in the patient's eye on (b)(6) 2017.When the lens was implanted, the doctor noticed that the bag tore.The doctor then exchanged it with a 3 piece lens.There was no patient injury.
Additional Manufacturer Narrative
Patient code changed from 3191 to 2639: posterior capsular bag tear.Lens was exchanged intraoperatively.(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: 6987328
• Report Number: 2023826-2017-01636
• Device Sequence Number: 16430556
• Product Code: HQL
• UDI-Device Identifier: 00841542102377
• UDI-Public: 00841542102377
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2017

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
• 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: 10/04/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 01/03/2018
• 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
• Patient Age: 55 YR