MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	DIU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the after the preloaded intraocular lens (iol) was implanted in the left eye (os), the patient complained of blurred vision and halos at all distances.Target was intermediate vision.The last refraction for the os was -1.75+0.75x020.The patient desires iol exchange for better vision and less halos.The initial cataract surgery operative report was received.The description of the procedure includes the surgeon's standard pre-operative, intra-operative, and post-op cataract surgery steps which were followed with no complications.No secondary surgical or medical interventions were performed.Additional information was received reporting that the surgery is scheduled for (b)(6)2024 and has not been performed yet.It was further noted that the patient complains of halos with lights.No quality issue with the device was noted.There was no patient injury and no medical or surgical intervention was performed.Through follow-up, it was learned that the explant procedure was performed on (b)(6), 2024.Another johnson and johnson iol was implanted as replacement (diu225).The patient was doing well at one day post-operative visit.No further information was provided.
Additional Manufacturer Narrative
Date of event: unknown; requested but not provided.The best estimate date is between nov 20, 2023 and mar 28, 2024.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no similar complaints for this production order number have been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19184570
• Report Number: 3012236936-2024-01191
• Device Sequence Number: 7403195
• Product Code: MJP
• UDI-Device Identifier: 05050474746596
• UDI-Public: (01)05050474746596(17)241213
• Combination Product (Y/N): N
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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: Health Professional
• Device Expiration Date: 12/13/2024
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U225
• 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: 04/02/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female