MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number	PCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intraocular lens was removed and replaced during the same procedure.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the doctor had to change the intraocular lens (iol) due to a broken capsule.Through follow up, the customer provided additional information confirming that the iol was fully inserted and that there was no incision enlargement, no serious patient injury and no sutures.A vitrectomy was performed and the patient is doing is well post-procedure.A 3-piece lens was used to complete the procedure.No additional information was provided to johnson and johnson surgical vision, inc.
Additional Manufacturer Narrative
Correction: the initial mdr inadvertently reported that the patient outcome was satisfactory, but patient outcome is unknown.Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed no additional investigation requests for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7517402
• Report Number: 2648035-2018-00716
• Device Sequence Number: 1385266
• Product Code: HQL
• UDI-Device Identifier: 05050474558427
• UDI-Public: (01)05050474558427(17)190912
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2018
• Report Date (Section F): 01/01/2005

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: 09/12/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 07/24/2018
• 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
• Date Report Sent to FDA: 01/01/2005