MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: n/a (not applicable).The intraocular lens remains implanted.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient was having an intraocular lens (iol) exchange in the right eye as it was superiorly displaced.The patient experienced decreased visual acuity.During follow up, it was reported that instead of an iol exchange, the doctor performed an iol rotation surgery.The iol repositioning surgery was performed on (b)(6) 2018.The iol rotation was not greater than 10 degrees.There was no incision enlargement, no sutures, no vitrectomy and no other medical or surgical intervention required.The patient was doing fine when discharged.No additional information was provided to johnson and johnson surgical vision, inc.
Additional Manufacturer Narrative
The product testing could not be performed as the product remains implanted.The reported complaint cannot be confirmed.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.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.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): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7344211
• Report Number: 3011852734-2018-00030
• Device Sequence Number: 1741063
• Product Code: HQL
• UDI-Device Identifier: 05050474531659
• UDI-Public: (01)05050474531659(17)210511
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/11/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000170
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 04/22/2018
• 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
• Patient Age: 70 YR