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

Model Number	ZCB00
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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 a zcb00 27.0 diopter intraocular lens (iol) was implanted in the patient's operative eye.It was later explanted due to unexpected myopic outcome.No additional information was provided.
Additional Manufacturer Narrative
The affected eye was the left (os).The replacement lens was a model zcb00, a smaller, 25.5 diopter lens.Patient is doing fine.There was no incision enlargement, vitrectomy, or sutures required.Age/date of birth: (b)(6).Gender/sex: female.If implanted, give date: (b)(6) 2017.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to the specifications.A search revealed that no other complaints were 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 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: 7229874
• Report Number: 2648035-2018-00171
• Device Sequence Number: 869123
• Product Code: HQL
• UDI-Device Identifier: 05050474531857
• UDI-Public: (01)05050474531857(17)200329
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2018

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: 03/29/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000270
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 03/14/2018; 05/30/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 04/13/2018; 06/20/2018
• 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