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

Model Number DIU525

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blurred Vision (2137); Visual Impairment (2138)

Event Date 05/31/2022

Event Type  Injury  

Event Description

It was reported that a post-operative (op) patient was having anisometropia and diplopia due to residual astigmatism.The intraocular lens (iol) was eventually explanted from the patient¿s right eye.Another lens, model diu150, 18.0 diopter was used as a replacement.Sutures on the main wound were used and no other interventions indicated.There was no injury and the patient¿s outcome were reported to be good.Allergic reaction to post-op medication reported, but they switched medications and the patient is doing much better.No further information was provided.

Manufacturer Narrative

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 review was performed, and no nonconformity report was found as part of this manufacturing records review.The product was manufactured and released according to specification.The search revealed that no other 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: sep 20, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received in a non-johnson & johnson sterilization pouch.Visual inspection under magnification revealed that the lens was received cut in half and with a detached haptic.No defects that could contribute to visual issues were observed.Based on the return condition of the lens no further evaluation could be performed.The complaint issue ¿blurry vision¿ and ¿diplopia-persistent¿ was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: 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: 15317259
• MDR Text Key: 298872378
• Report Number: 3012236936-2022-02292
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474749375
• UDI-Public: (01)05050474749375(17)250222
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

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
• Device Operator: Health Professional
• Device Model Number: DIU525
• Device Catalogue Number: DIU525U140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 10/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White