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	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted; give date: lens remains implanted, therefore not explanted.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 during implantation a small, white plastic piece was introduced into the eye together with the trailing haptic.It was removed and kept without any complications.No issues for the patient noted.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 foreign material was received on 01-10-2021 at amo puerto rico manufacturing / johnson and johnson surgical vision.The white particle was observed on the cartridge tip cap.The foreign material was sent to eag lab for further analysis.The material was analyzed by fourier transform infrared (ftir) spectroscopy and results shows that this material is consisted with abs.Even though the abs material is part of the plunger component, it is not possible to determined that this particle belongs to it since the preloaded device are not available for a thoroughly evaluation.The complaint issue reported could not be verified.However, throughout the manufacturing process there are various process controls steps that will identify and discard a unit with ¿dc-foreign material ¿ loose¿ condition.Based on the stated above, the manufacturing process have controls to identify and discard units with ¿debris/particulates¿ and devices are processed within a classified controlled environment.Based on the foreign material results and the manufacturing controls in-place, it is not possible to confirm if the foreign material observed is related to the manufacturing process, as the reported units were handled.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: 10834661
• Report Number: 2648035-2020-00848
• Device Sequence Number: 11490246
• Product Code: HQL
• UDI-Device Identifier: 05050474558359
• UDI-Public: (01)05050474558359(17)230207
• Combination Product (Y/N): Y
• Initial Reporter Country: FI
• 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): 02/19/2021

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: 02/07/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2021
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1