MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number	PCB00
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as the lens remains implanted.  (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient is experiencing blurry vision in left eye and visual acuity is 20/60 post implant of a pcb00 27.0 diopter intraocular lens(iol).Surgeon thinks there may be labelling error and also reported that there is refractive error at -1.93.Reportedly there is no plan to explant the lens right now because the patient doesn't want to do it at this time, however surgeon is considering lasik and also noted there were sutures used on the cornea to correct astigmatism.The patient was reported to be doing fine when discharged.No further information provided.
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 specifications.A search revealed that no other complaint was received for 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 ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION; santa ana CA
• MDR Report Key: 7539672
• Report Number: 2648035-2018-00768
• Device Sequence Number: 1818728
• Product Code: HQL
• UDI-Device Identifier: 05050474558403
• UDI-Public: (01)05050474558403(17)200109
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018
• Report Date (Section F): 01/01/2005

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: 01/09/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000270
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 08/23/2018
• 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: 66 YR
• Date Report Sent to FDA: 01/01/2005