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	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If explanted; give date: not applicable, there is no indication the lens was removed or explanted from the eye.(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 the injection of an intraocular lens, model pcb00 in the patient's right eye, a white plastic piece measuring about 0.5 mm was found attached to the edge of the iol, later freeing and floating in the anterior chamber.A capsulorhexis forceps was used to extract it.Piece removed immediately from eye with no ill effect to patient.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no additional investigation were received for this production order number.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.
Additional Manufacturer Narrative
Additional report submitted, due the fact that product was returned for visual evaluation.New information received.Device available for evaluation? : yes, product returned to manufacturer on 10/1/2019.Device evaluation: the particle was sent to eag lab for further analysis.The analysis of a white foreign particle (cf# (b)(4)) showed that it was consistent with abs (acrylonitrile/butadiene/styrene).The preloaded device was disassembled to evaluate upper and lower body and plunger -nut-pushrod assembly under microscope.During the verification of the bodies and plunger-nut-pushrod assembly, no flash or parting line that exceed specification was identified, however, a small white particle was identified over the plunger thread.Plunger-nut fitting assembly was evaluated and identified as a tight fitting with no freely rotation observed.These three components were evaluated when disassembled and a small excess of plastic was observed in the internal thread of the nut that may alter the freely rotation of nut-plunger assembly.Based on the evaluation performed, plunger(p/n 193164) is composed of abs, therefore during the manufacturing process there was exposure to abs materials.As per hra3026-3¿tecnis itec preloaded process fmea¿, contamination particles may be caused by potentially fail to met design/process requirements during the alignment of plunger with nut, alignment of iol push rod with the nut and plunger assembly, specifically during the sub assembly of preloaded components.All the manufacturing steps are performed in a regulated clean manufacturing room, following (b)(4) gowning procedures and practices at (b)(4).This complaint is confirmed.However a new nr is not required.Conclusion based on the analyzed of the returned and eag lab results, there is an indication of a product malfunction.However, the unit was manufactured prior to the initiation of (b)(4) which addressed the corrections of mold insert at supplier level specifically for cavity 2 from mold al-25 for nut part number 193024.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

• 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: 8825052
• Report Number: 2648035-2019-00765
• Device Sequence Number: 16190135
• Product Code: HQL
• UDI-Device Identifier: 05050474557987
• UDI-Public: (01)05050474557987(17)201128
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/11/2020
• Report Date (Section F): 01/01/2005

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: 11/28/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 08/21/2019; 11/13/2019; 10/25/2020
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 09/16/2019; 12/10/2019; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005