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

Model Number	PCB00
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: 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.(b)(6).Investigation results iol example: device evaluation: since product was not returned, the complaint issue reported could not be verified.Product 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.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.
Event or Problem Description
It was reported that during a cataract surgery, the intraocular lens did not came out of the inserter.Lens was partially delivered.No patient injury, no wound enlargement, no vitrectomy performed.All the information available have 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 (b)(4).
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 9/1/2020 device returned to manufacturer? yes.The product was received on 09/01/2020 at johnson and johnson surgical vision manufacturing.Visual inspection was performed to the returned sample.The plunger and pushrod was observed in advanced position.The pushrod was observed that overrides the lens in the cartridge.Residues of lubricant material was observed on cartridge.The cartridge tip was observed slightly deformed.The lens was also observed stuck in cartridge.The condition in which the sample returned was consistent with a product that was handled and prepared for a surgical process.The complaint issue reported was verified.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed no additional complaint folder has been 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 & 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: 10445745
• Report Number: 2648035-2020-00638
• Device Sequence Number: 14468114
• Product Code: HQL
• UDI-Device Identifier: 05050474558243
• UDI-Public: (01)05050474558243(17)230110
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• 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: 01/10/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 10/25/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/24/2020; 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