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

Model Number	DXW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between 6/30/2023 and 12/21/2023.The device was not returned for evaluation.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient had slight blurriness after implanting tecnis symphony toric intraocular lens (iol).Physician was giving her time to heel.Additional information received confirmed that the patient does not have any debilitation condition due to blurriness.No further medical intervention was required.Currently patients' vision is slightly blurry.Doctor plans for lasik enhancement future visit.Through follow up, it was learnt that at the present moment patient has not had lasik enhancement, however patient is scheduled for a follow up appointment 10/5/23.Further follow up information revealed that patient had a follow up appointment on 10/16/2023.Doctor continues to monitor the patient, currently no further treatment is needed.Additional information received stated that the original lens was explanted.Doctor decided to do the explant on (b)(6) 2023.There was no patient injury.No other medical or surgical intervention required.The original lens was replaced with zcb00 11.5 diopter lens.Patients outcome was reported as patient must improve and her vision was much better and her lens was in a good position on one day post explant.No further information is available.
Additional Manufacturer Narrative
Additional information: additional information received stated that during the patients' procedure, prior to explanting the lens, the doctor cut the lens with micro surgical scissors for safe removal of the lens.Lens is then placed in the cartridge for return.Section d9: device available for evaluation: yes section d9: returned to manufacturer on: 01/29/2024 section h3: device evaluated by manufacturer: yes device evaluation: visual inspection of the lens reveals that the lens was coated in viscoelastic residue with the haptic region of the lens torn off.The lens was cleaned and no issues that could cause the complaint issue was observed.The torn portion of the lens remained inside the non-j&j cartridge.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 18624154
• Report Number: 3012236936-2024-00273
• Device Sequence Number: 7668186
• Product Code: HQL
• UDI-Device Identifier: 05050474762800
• UDI-Public: (01)05050474762800(17)260507
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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: 05/07/2026
• Device Model Number: DXW150
• Device Catalogue Number: DXW150U115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/05/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2023
• 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 Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White