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	Corneal Edema (1791)
Date of Event	09/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted; therefore, it was not explanted.Device evaluation: the pcb00 preloaded insertion system unit was received in its original box.The cartridge component was observed correctly engaged into lower body of the pcb00 device.The plunger component was observed in advanced position.Visual inspection using microscope magnification was performed.Only a detached haptic was observed stuck at the cartridge tube, near the tip.The rest of the lens was not returned.Residues of lubricant were observed at the cartridge tip which was deformed.The condition observed is consistent with preloaded unit used.No manufacturing defects were detected.The reported issue could not be confirmed on the return.No product deficiency was identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) had a loading issue.The lens was partially inserted and removed in the same procedure as the surgeon had to cut the haptic out from the patients right eye.There was no vitrectomy, incision enlargement or sutures required.Another johnson & johnson lens (same model and diopter) was implanted as a replacement.Patient post-operative (op) status day 1 was 20/250 visual acuity (va) due to corneal edema.Through follow-up, it was learned the corneal edema did not resolve within the 2 weeks post-op.At 4 weeks post-op residual edema persists, vision 20/30.Patient has a scheduled follow-up in 2 weeks.The patient is kept on steroid drops.No further information provided.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted that in the initial mdr section g4 had the incorrect date received by manufacturer.The correct date is 10/20/2020.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: 10857350
• Report Number: 2648035-2020-00861
• Device Sequence Number: 19463262
• Product Code: HQL
• UDI-Device Identifier: 05050474558359
• UDI-Public: (01)05050474558359(17)230622
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR