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

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was not fully implanted.If explanted, give date: not applicable, as lens was not implanted, then not removed.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during cataract surgery, the intraocular lens (iol) ran out of the cartridge and the doctor was unable to push the iol into the eye.It was indicated that the lens was damaged.They used another lens to complete the operation.The event caused a delay in the procedure; however, the delay was not clinically significant and no additional anesthesia was required.There was no patient injury reported.No additional information was provided.
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 evaluation: the device was received in its original packaging with intraocular lens implant notification card, patient lens implant identification card, and label stickers.The plunger was observed in a fully advanced position and all the components were correctly engaged.No assembly error and/or defect related to the manufacturing process was observed in the device.Visual inspection performed under microscope and lack of lubricating material was observed in the device.The lens was not returned for evaluation.No damaged/defect was identified in the product returned that may lead the reported conditions.Since the lens was no returned for evaluation the reported issues could not be verified.Based in the analysis the product quality deficiency could not be determined.All pertinent information available to johnson and johnson surgical vision has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated, and no deviation was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson and johnson surgical vision 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: 10197752
• Report Number: 2648035-2020-00457
• Device Sequence Number: 2925270
• Product Code: HQL
• UDI-Device Identifier: 05050474558236
• UDI-Public: (01)05050474558236(17)220610
• Combination Product (Y/N): Y
• Initial Reporter Country: CN
• 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: Physician
• Type of Report: Initial,Followup,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: 06/10/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 07/14/2020; 09/08/2020; 10/25/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 08/07/2020; 10/01/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Date Report Sent to FDA: 01/01/2005