MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number	PCB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If explanted; give date: lens remains implanted.Phone: (b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after implanting the lens the surgeon saw a particle.This was removed an returned.No impact on the patient was reported.No additional information was provided.
Additional Manufacturer Narrative
Section d10 - device available for evaluation? yes.Section d10 - returned to manufacturer on: 1/10/2021.Section h3 - device evaluated by manufacturer? yes.Section h3 - device returned to manufacturer? yes.Device evaluation: the device was returned in its original packaging.The plunger was observed fully advanced and a tweezer with a plastic cap on and wrapped with adhesive tape was also received in the box.The foreign material was in the tweezer tip, and it was sent to eag laboratories as received for further analysis.Based in the eag lab.Analysis, the foreign material was transferred to an infrared transmitting substrate and analyzed in transmission mode using a perkinelmer spectrum spotlight 200 fourier transform infrared (ftir) spectrometer equipped with a microscope.The analytical spot size was approximately 100 microns x 100 microns.Perkinelmer spectrumir software was used to perform data analysis.The particle was received on the tip of a tweezers which had been covered with a plastic cap and secured with tape.Photographs which accompanied the sample identified the material of interest and its location on the tweezer tip.Ftir analysis indicates that the particle is consistent with a mixture containing a fatty amide/wax (e.G.Stearamide, oleamide, erucamide) and silicone.These types of waxes are common additives to plastics and lubricants for plastic bags.Our product can be expose to different materials during the manufacturing process (i.E.Processing aids).However, these types materials are not part of our working materials and does not match with any of the component of the final product.Based on the evaluation performed, the manufacturing process have controls to identify and discard units with this type of issues.Also, the manufacturing record review and sterilization record review show that the product was made and sterilized according specification and parameters established in the procedures.Based on the manufacturing controls in-place, evidence observed, and the batch record reviewed, the reported complaint cannot be confirmed as manufacturing process related.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.  a search revealed that no additional complaints for this 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 and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11070816
• Report Number: 2648035-2020-00966
• Device Sequence Number: 19723210
• Product Code: HQL
• UDI-Device Identifier: 05050474558168
• UDI-Public: (01)05050474558168(17)230708
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2021
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 12/24/2020
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1