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

Model Number	PCB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed since the product was discarded.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.There are no discrepancies found during the mrr (manufacturing record review).The search revealed one complaint from this production order number, however the reported issue is unrelated to this reported complaint and no product deficiency was identified in that case.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.
Event or Problem Description
It was reported that a pcb00 model intraocular lens(iol) was inserted into patient's right eye and noticed that there was scratches on the iol while observing the lens under the microscope.The lens was removed and replaced during the same procedure and was completed successfully using backup lens of the same model and diopter.The lens was discarded.There was no patient injury.One day post-operative (op) patient reported blurry vision, however, no other complaints.No further information available.
Additional Manufacturer Narrative
Additional details received states that the incision was made larger to get the lens back out.Upon further review of the reported event, it was observed that the event of blurry vision was not due to implantation of the reported lens but due to implantation of replacement lens into patient's eye; therefore, blurry vision was inadvertently captured in the initial report.The blurry vision event was observed on day one after procedure was completed successfully using the backup lens.Further follow up confirmed that now patient did not have any issues with implantation of the replacement lens.Additional patient details were also received.As a result, the following fields have been updated: section a5: additional data : race- white.Section b1: correction: in initial report, the correct report type should have been only product problem.Section b2: correction: in initial report, outcomes attributed to adverse event should have been left blank.Section h1: correction: in initial report, the correct type of reportable event should have been malfunction.Section h6: additional data: health effect- clinical code 4581- incision enlargement.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
• MDR Report Key: 12291869
• Report Number: 2648035-2021-08273
• Device Sequence Number: 3164811
• Product Code: HQL
• UDI-Device Identifier: 05050474558243
• UDI-Public: (01)05050474558243(17)220615
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 08/08/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 09/01/2021
• 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: Other