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

Model Number	PCB00
Medical Device Problem Codes	Failure to Fold (1255); Failure to Eject (4010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Date of event: unknown/ not provided.If implanted; give date: n/a (not applicable).The intraocular lens was partially inserted and removed during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was partially inserted and removed during the same procedure.Phone: (b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the trailing haptic of an intraocular lens, model pcb00 came out first from the cartridge during a cataract surgery.Issue observed during insertion.As per follow-up was learned that the lens was stuck in cartridge.No patient injury reported.All the information available were 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 nr-0148919 and capa-010215.
Additional Manufacturer Narrative
Additional information: section d-10: device available for evaluation: yes.Section d-10: returned to manufacturer on: 01/24/2020.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the product monofocal intraocular lens, model pcb, was returned at site on 01/24/2020.A visual inspection was performed to the device sample returned.The plunger and pushrod was observed in advanced position.No residues of lubricant material were observed on cartridge.The lens stuck in cartridge and lead haptic not folded was observed.The cartridge tip was observed in good conditions.The complaint issue was verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.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.

• 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: 9520963
• Report Number: 2648035-2019-01378
• Device Sequence Number: 16913976
• Product Code: HQL
• UDI-Device Identifier: 05050474558151
• UDI-Public: (01)05050474558151(17)211220
• Combination Product (Y/N): Y
• Initial Reporter Country: SE
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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: 12/20/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 02/04/2020; 10/25/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/03/2020; 11/05/2020
• 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