MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DFW300
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: the device was not returned for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Health effect - clinical code: code 4581 is to capture device decentered or dislocated or tilted subluxated or wrong position : device dislocation.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the intraocular lens (iol) was fully implanted in the left eye, the toric iol moved.On (b)(6) 2022, the iol was perfect, however on (b)(6) 2022, the iol had rotated 10 degrees and 1mm inferior decentration.The patient does not have any pre-existing conditions that could have contributed to the event.The patient's daily activities were significantly affected due to glare and decreased distance vision.The patient is not happy with distance vision.The patient's pre-operative visual acuity (va) was 20/40 with correction (cc), and post-operative va was 20/20 cc.No medical or surgical intervention has been performed for this issue.The iol will be explanted during a secondary procedure, but it has not yet occurred.No further information was provided.
Additional Manufacturer Narrative
Corrected data: in reviewing the initial mdr 3012236936-2023-00153, it was noticed that the following information for section b5 was inadvertently not included; therefore, it is captured in this supplemental report: it was reported that when the lens was perfect in every regard, the patient was unhappy.The issue is the lack of crispness in distance and halos at night when driving.The patient is going for a second opinion.Section h6: 2227 - halo.It was also noted that "g4" field which should have been populated with "no" was inadvertently left blank on the initial mdr; therefore, the information has been corrected in this supplemental mdr report and the following fields have been updated accordingly: section g4: combination product: no.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16212249
• Report Number: 3012236936-2023-00153
• Device Sequence Number: 4341361
• Product Code: MFK
• UDI-Device Identifier: 05050474752436
• UDI-Public: (01)05050474752436(17)241126
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: 11/26/2024
• Device Model Number: DFW300
• Device Catalogue Number: DFW300U195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Race: White