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

Model Number	ZCT150
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Inaccurate Information (4051)
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); No Code Available (3191)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye).Iol was explanted due to complaint of significantly hyperopic and replaced with a different model and different diopter size lens.After running numerous tests and checking his calculations multiple times, the doctor is concerned the lens implanted may be mislabeled.Through follow-up, additional information was received confirming normal daily activities are affected.There were no complications and no vitrectomy.Planned incision enlargement was performed in the primary temporal wound and enlarged to about 3.0 mm.One (01) 10-0 nylon suture was placed; this was planned to be done at the time of iol exchange.Patient outcome was reported as: healing normally but he is now myopic (about -2.00 but pending final refraction in a few weeks).He will now require full time glasses or ctl wear or a 3rd surgery (lasik or prk) to give him the intended refractive outcome.In the doctor's opinion, this unintended refractive outcome is a direct result of the iol being mislabeled.No further information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review, the device code labeling issues was inadvertently left out in the initial mdr report.Also, replacement lens was noted to be a zcb00 25.5 diopter power, serial number (b)(6).Section h6: device code: 2911.Section h-6: patient code 3191 - suture(s) that was reported in the initial report is no longer applicable as the doctor clarified the suture was planned.Additional information: upon further follow-up, it was learned that the patient has uncorrected distance visual acuity (ucdva) = 20/20 now but he still complains of a haze over his vision and has diffuse corneal superficial punctate keratitis (spk).The doctor is managing the patient with artificial tear drops, and hopes his cornea will continue to clear up over time and will be happy with his vision.The following fields were updated accordingly: section d-10: device available for evaluation: yes.Section d-10: returned to manufacturer on: 11-dec-2020.Section h-3: device returned to manufacturer: yes.Device evaluation: the returned iol measured as zct150 17.50d.The expected measurement was zct150 23.5d.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no other complaints for this production order number have been received.Conclusion: as a result, of the investigation a field action was initiated on (b)(6) 2021.The reported issue was verified and a capa-010395 was opened to address the issue.The investigation is ongoing; however, to date, the investigation has identified that the handling of rejected lenses is a likely contributing factor, as it increases the possibility of a scrapped lens being labeled as an approved lens in a daisywheel.Investigation has shown the following preliminary causes: lens mix-up of an approved and reject product within the same production order at the inline manufacturing inspection station.Immediate actions taken as a result of preliminary investigation include: all inventory units (distribution center and consignment) for the impacted lot have been received or in the process of being returned.Manufacturing technicians performing inline measurement inspection station have been made aware of the issue through training for awareness of this complaint and correct procedures to follow.All technicians working at the lens generation station were retrained on the process.Manufacturing controls have been enhanced which include: 1) implementation of segregated reject tray during final inspection process for holding reject lenses 2) train on current sop (b)(4) to only allow processing and handling of one lens at a time 3) implementation of daily process confirmations where qa representative confirms adherence to final inspection instructions including proper use of the reject tray and processing one lens at a time during final inspection steps.Jjsv will issue a recall notification letter to impacted customers.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.; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 10972687
• Report Number: 9614546-2020-00511
• Device Sequence Number: 17217065
• Product Code: HQL
• UDI-Device Identifier: 05050474552210
• UDI-Public: (01)05050474552210(17)221123
• 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
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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: Health Professional
• Device Expiration Date: 11/23/2022
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1928190
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR