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

Model Number	PCB00
Medical Device Problem Codes	Premature Activation (1484); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	03/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable as the lens reamins implanted and therefore not explanted.(b)(6).Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site as to date it remains implanted.Therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.The dfu states ''fully advance the lens by pushing the plunger forward in one smooth, continuous motion until the black band on the plunger is no longer visible and a hard stop is perceived.Ensure that the plunger is locked by gently pulling back on the plunger.If the plunger does not pull back, then it is properly locked and the lens is now ready to be delivered.'' as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that when the surgeon attempted to inject the intraocular lens (iol) into the patient's eye, the lens would not come out of the cartridge.The surgeon concluded that the push rod was not engaged to the second step and pushed again.After this, the lens shot out, perforated the capsule and disappeared into the posterior segment.Additional information was received and it was learnt that the lens was implanted in the sulcus after retrieving it from the back of the eye.Reportedly, the lens remains implanted.The incision was enlarged, a vitrectomy was performed and sutures were used.No additional information was provided.

• 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: 7471354
• Report Number: 2648035-2018-00624
• Device Sequence Number: 1592575
• Product Code: HQL
• UDI-Device Identifier: 05050474558106
• UDI-Public: (01)05050474558106(17)190707
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2018

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: 07/07/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/28/2018
• 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: 71 YR