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

Model Number	ZCT450
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2018.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Initially it was reported that there was a tecnis toric calculator error.The calculation for the intraocular lens came out with +24.5 but the lens should have been +14.5 or thereabouts.Through follow up it was clarified that it was not a calculator error but a data entry error into the calculator by a technician.The implanted lens (model zct450 +24.5 diopter) was subsequently explanted in a secondary procedure.At explant, the incision was enlarged and a model zct300 +15.0 diopter was implanted as a replacement.The patient was reported to be doing good at discharge.No further information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation ¿ yes, returned to manufacturer on 2/21/2018.Device returned to manufacturer ¿ yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Visual inspection performed by a qualified operator using 12x magnification shows the product is cut in half, most probably to make explant possible, it also showed that a haptic was missing.The lens is contaminated, dust particles are present.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.The customer's reported complaint was not verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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
• MDR Report Key: 7311383
• Report Number: 9614546-2018-00212
• Device Sequence Number: 19135707
• Product Code: HQL
• UDI-Device Identifier: 05050474603073
• UDI-Public: (01)05050474603073(17)201001
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 10/01/2020
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 05/22/2018
• 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