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

Model Number	PCB00
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Material Deformation (2976)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant date: if explanted; give date: not applicable (n/a) as the lens remains implanted and therefore not explanted.(b)(4).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 additional complaints for this production order have been received.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.
Event or Problem Description
A reported was received from a patient complaining of double vision after the intraocular lens (iol) implantation in the left eye (os) on (b)(6) 2018.Reportedly, the issue began 3-4 days post-operation.It was noted that the patient's pre-op measurement was 20/25 +2.00 and the post-op measurement on (b)(6) 2018 was 20/30 +1.00.Refraction was done on the same day with the trial frame, and then the patient was not experiencing double vision anymore; his measurement was 20/15.Additional information revealed that there was no patient injury and no secondary surgical intervention was required.Patient stated that the surgeon noticed that the iol had a crease in it so it didn't unfold correctly.Consequently, the patient discussed any options with his surgeon who advised that glasses would take care of the double vision.The patient also reported having glare, but the surgeon did not address that issue.No additional information was provided.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-(b)(4).

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7665968
• Report Number: 2648035-2018-00950
• Device Sequence Number: 1619312
• Product Code: HQL
• UDI-Device Identifier: 05050474558441
• UDI-Public: (01)05050474558441(17)190429
• Combination Product (Y/N): Y
• 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: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020
• 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: Health Professional
• Device Expiration Date: 04/29/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 10/30/2020
• 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: Other
• Date Report Sent to FDA: 01/01/2005