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

Model Number PCB00

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

Age/ date of birth: unknown, information not provided.Gender/ sex: unknown, information not provided.If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens (iol) fell to back of the eye with lens not inserted.As to explain the event, iol decentrations to iol luxation involves the total dislocation of the lens to the posterior segment (vitreous chamber) is considered a serious complications that requires intervention if possible immediate.No further information provided.

Manufacturer Narrative

Corrected data: information was known at the time of previous filing the patient was left without a replacement lens, however was inadvertently not included.Therefore, the following patient code has been added; section h6: patient code 3191 ¿ aphakic.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

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 nr-0148919 and capa-010215.

Manufacturer Narrative

Additional information: section d10: device available for evaluation ¿ yes, returned to manufacturer on 8/25/2020.Section h3: device returned to manufacturer ¿ yes.Device evaluation: it was returned in its original packaging and there was a note on the box that stated lens fell to back of eye.Unable to place different lens.Patient was referred to retinal specialist.All the components look correctly engaged to the device.No assembly error and/or defect related to the manufacturing process was observed.Visual inspection performed under microscope: lack of lubricating material was observed in the device.The lens was stuck at the cartridge tube, and it looks in a correctly folding position.Based in the information provided and the analysis of the product returned the reported issues could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the device were reviewed.There was no discrepancy and/or deviation found during the mrr (manufacturing record review).The product was manufactured and released according to specification.A search in complaint system revealed that two additional complaints were received from this production order with one complaint where no product deficiency was identified and another complaint meets the criteria for no further investigation per johnson & johnson surgical vision complaint handling procedures.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 & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10449368
• MDR Text Key: 204232316
• Report Number: 2648035-2020-00641
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558250
• UDI-Public: (01)05050474558250(17)221031
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2005,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 08/28/2020; 10/06/2020; 10/25/2020
• Supplement Dates FDA Received: 09/23/2020; 10/30/2020; 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other