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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
It was reported that during implantation, the intraocular lens(iol) came out of the cartridge without the trailing haptic.The haptic/optic touched the patient's eye.The patient experienced double vision after the surgery; therefore, the iol was explanted and replaced with a new iol.Reportedly, there was no patient injury.No additional information was provided to johnson & johnson surgical vision, inc.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 3/23/2018.Device returned to manufacturer? yes.Device evaluation: the product return was evaluated.The plunger was advanced and locked as product preparation requires.No viscoelastic was observed in the device.The lens was returned in a small sampling container.The lens was missing a haptic (detached) therefore, the reported issue was verified.The detached haptic was observed stuck at the cartridge tube.Per directions for use, the use of viscoelastics is required when using the tecnis itec preloaded delivery system.Based on the product evaluation, a cause of failure related to the device manufacturing process was not determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: 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.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 7387418
• Report Number: 2648035-2018-00437
• Device Sequence Number: 1161065
• Product Code: HQL
• UDI-Device Identifier: 05050474558182
• UDI-Public: (01)05050474558182(17)181124
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Followup
• Report Date (Section B): 04/24/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/24/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 04/24/2018
• 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