MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens was explanted from the patient's eye because the incorrect diopter size was implanted.Reportedly a zcb00 +28.0 diopter was implanted instead of a zcb00 +20.0 diopter.Apparently the carton box stated zcb00 +20.0 but the lens inside was a zcb00 +28.0 instead.They discovered it because the stickers in the patient¿s chart showed it was a zcboo +28.0.The carton box was discarded by the customer.A zcb00 +20.0 was then implanted as a replacement and the patient was reported being fine.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site.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 product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been 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.Additional information received reported the implant date was (b)(6) 2018, and the explant date was (b)(6) 2018.Lens was replaced with an unknown type lens.There was an incision enlargement performed and one (1) suture was used.The reason for the explant was because of an unexpected post-operative refraction, with a visual acuity of 2500, at the patient's 1-day post-operative visit.The patient's current visual acuity is 20/40 uncorrected and 20/20 corrected.The patient is a male, with a date of birth of (b)(6), and operative eye was the right.No additional information was provided.Age/date of birth: (b)(6).Gender/sex: male.If implanted, give date: (b)(6) 2018.If explanted, give date: (b)(6) 2018.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7298354
• Report Number: 2648035-2018-00296
• Device Sequence Number: 13870872
• Product Code: HQL
• UDI-Device Identifier: 05050474531871
• UDI-Public: (01)05050474531871(17)210605
• Combination Product (Y/N): N
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

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: 06/05/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 03/29/2018
• 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