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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); No Code Available (3191)
Date of Event	08/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: the product testing could not be performed because the product was not returned for evaluation (it was confirmed that product is not available for investigation).The complaint cannot be confirmed.Manufacturing record review: manufacturing record review for this production order was evaluated and the devices were manufactured within specifications.A search of complaints revealed that no other complaint was received from 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: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was initially reported that a female patient was scheduled for an iol explant, model zcb00 (26.5 diopter) on the right eye (od) due to myopic surprise, the patient had decreased visual acuity.It was confirmed that the explant was performed on (b)(6) 2017 and the replacement lens was the same model but a lower diopter (24.5).It was reported that the patient was doing well when discharged.There was no incision enlargement required, no vitrectomy performed and no other medical or surgical intervention was required.No further information was provided.Visual acuity pre-op (pre-initial implant) 20/50, visual acuity post-op (post-initial implant) 20/60, visual acuity post-op (post-replacement) 20/25.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6844182
• Report Number: 2648035-2017-01602
• Device Sequence Number: 13830740
• Product Code: HQL
• UDI-Device Identifier: 05050474531840
• UDI-Public: (01)05050474531840(17)210502
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2017

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: 05/02/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 09/05/2017
• 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
• Patient Age: 57 YR