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

Model Number	ZCB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/not provided.If implanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported after insertion of an intraocular lens (iol) in the patient's left eye, debris was observed on the lens.The lens was removed and replaced in the same procedure.The patient has recovered.No further information was available.
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 (b)(4).
Additional Manufacturer Narrative
Additional information: device available for evaluation? yes.Returned to manufacturer on: 8/10/2020 device returned to manufacturer ¿ yes.Device evaluation: visual inspection under magnification revealed a detached haptic, what appeared to be viscoelastic residue on the optic body and haptics, and that the lens was received cut in half, which is consistent with a lens that was handled during removal and replacement.Furthermore, a fiber was observed on the optic body of the lens half with the detached haptic, which may have been the ¿debris on lens¿ described by the customer.The lens and foreign material were forwarded to eag laboratories for foreign matter analysis.The lens was sent to eag laboratories for further analysis of what appeared to be a fiber on the optic body, which may have been the "debris on lens" as described by the customer.Ftir analysis indicates that the foreign material is a mixture of a cellulosic material (e.G.Cotton, rayon, lint) and an inorganic carbonate similar to calcium carbonate.The complaint issue was confirmed, however due to the low correlation (correlation less than 0.90000) between the foreign material and the añasco manufacturing process ftir library it cannot be confirmed if the issue is related to handling or manufacturing, because añasco has manufacturing controls in place to prevent the release of product with foreign material on it, and therefore no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints revealed two other complaints were received under this production order; however, these complaint issues are unrelated; therefore, no escalations are required.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.

• Brand Name: TECNIS 1-PIECE
• 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: 10434194
• Report Number: 2648035-2020-00628
• Device Sequence Number: 16742248
• Product Code: HQL
• UDI-Device Identifier: 05050474531635
• UDI-Public: (01)05050474531635(17)231009
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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: 10/09/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 09/11/2020; 10/25/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 10/06/2020; 10/29/2020
• 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