MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; TORIC IOLS

Model Number	ZCT150
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	04/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.If explanted; give date: n/a (not applicable).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 after the zct150 22.0 diopter intraocular lens (iol) was inserted, a capsule tear occurred.The doctor performed vitrectomy.The lens was removed and reportedly it was replaced with a sulcus 3 piece lens.There were no other interventions required and the patient outcome at the time of discharge was good.There was no patient injury reported.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 5/17/2018.Device returned to manufacturer? yes.Device evaluation: the device was received at the manufacturing site for investigation.Visual inspection shows there was cut on the lens most probably to make remove and replacement possible.The lens is dirty.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.Investigation of the return sample and the condition of the return sample do not suggest the dirt and cut was introduced during manufacturing.The complaint cannot be confirmed.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.Historical data analysis: a search in the complaint history was performed on (b)(6) 2018 revealed that no similar complaints were received 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: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7492234
• Report Number: 9614546-2018-00437
• Device Sequence Number: 18915613
• Product Code: HQL
• UDI-Device Identifier: 05050474552180
• UDI-Public: (01)05050474552180(17)210508
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018
• 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: 05/08/2021
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE, LOT#UNKNOWN; 1MTEC30 CARTRIDGE, LOT#UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005