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

Model Number	DIU300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient ethnicity: information unknown/not provided.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 due to a refractive error.Only part of the lens was able to be salvaged.Additional information was provided and reported the patient had post operative(op) hyperopic surprise since day 1 post-op.There was no patient injury and no report of any medical or surgical intervention required.Another johnson & johnson lens diu300 19.5 (same model and higher diopter) was implanted as a replacement.The patient's vision outcome post-op period is still blurry.No further information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 8/17/2021.Device evaluation: device was not returned for evaluation, only a half of lens was received inside a sample container.The lens was broken and lubricating material can be observed on its surface.The reported issue could not be verified and product quality deficiency could not be determined.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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.The search revealed that no similar complaint for this production order 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.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
• MDR Report Key: 12164334
• Report Number: 2648035-2021-08124
• Device Sequence Number: 14466159
• Product Code: MJP
• UDI-Device Identifier: 05050474747678
• UDI-Public: (01)05050474747678(17)240309
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2021

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: 03/09/2024
• Device Model Number: DIU300
• Device Catalogue Number: DIU300U175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 08/10/2021; 09/16/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/10/2021; 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 67