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

Model Number	DXW225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Additional 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 for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no similar complaint for this po number has 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.An attempt to obtain additional information was conducted, however, there is no additional information available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's left eye as the surgeon believes the lens was mislabeled.Additional information was provided that the patient was more myopic than anticipated.The patient was complaining of glare and decreased distance vision.There was no patient injury reported.There were no report of any vitrectomy, incision enlargement, or sutures being required.A non-johnson & johnson lens was implanted as a replacement iol.The patient outcome was reported as being right on target.Through follow-up, it was learned that the patient was off target and the formulas all looked correct, therefore, the surgeon was thinking the iol was mislabeled.There was no incorrect labels or incorrect labeling on the iol box.The surgeon just thought because of the amount of diopter the patient was off target, it led them to believe there was a mislabel or defect in the lens.The patient does not have any pathology in both eyes.No other information was provided.
Additional Manufacturer Narrative
Additional info: section d9: device available for evaluation? yes, section d9: returned to manufacturer on: nov 15, 2022, section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received stuck to the outside of a non-jnj lens case.Visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue.The lens was cleaned and, scratches on the lens were observed, consistent with a lens that was handled, could be identified.The complaint lens was sent to the manufacturing site for miq (measurement inspection quality) evaluation.After submersion in the disinfectant solution it was observed that the scratches on the lens were significantly diminished.The lens was measured using miq66 and had an acceptable reading of 24.54d.Conclusion: the decontaminated lens was received at the manufacturing site and presented with no cosmetic issues.The complaint issue lens damaged could not be confirmed.Miq measurement of the lens prior to being placed in the lens case and measurement of the return lens indicates that the correct lens was placed in the lens case.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
• 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: 15756941
• Report Number: 3012236936-2022-02777
• Device Sequence Number: 6239046
• Product Code: HQL
• UDI-Device Identifier: 05050474764248
• UDI-Public: (01)05050474764248(17)250712
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 01/10/2023

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: 07/12/2025
• Device Model Number: DXW225
• Device Catalogue Number: DXW225U245
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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: 70 YR
• Patient Sex: Female
• Patient Race: White