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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Corneal Edema (1791); No Code Available (3191)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.(b)(6).(b)(4).All pertinent information available to (b)(4) has been submitted.
Event or Problem Description
It was reported that lens model, pcb00 monofocal iol (intraocular lens) was broken when introduced into patient''s eye.As a result, lens was removed and replaced with the back-up lens in the same procedure.Incision was enlarged in order to remove the iol from the eye.Vitrectomy was required as well.The doctor also expressed dissatisfaction as he is no longer happy with the use of pcb00 preloaded lens.Through follow-up, there was no wound leakage, but patient has significant oedema.Patient''s anterior chamber (a/c) was clear and dark as no flare nor cells were observed.Posterior pole was flat with hazy view, disc & mac appear within normal limits.During the second patient''s post-op visit, his eyes are quiet, no stain and intraocular pressure (iops) are normal as stated.Patient''s a/cs were clear.Miops are within normal limits.Lt monofocal iol in situ found no inflammation at incision, no pigmentation, no poster chamber opacification (pco), posterior poles was flat, no cmo (cystoid macular oedema) and no uveitis.There were no cells nor flares in a/cs.Reportedly, patient outcome has improved.No additional information provided.
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 03/19/2019.Device evaluation: the preloaded delivery system (model pcb00) was returned at the manufacturing site for evaluation.The plunger, observed in fully advanced position, was gently pulled back and found locked.The pcb00 device was observed under the microscope and no viscoelastic was observed in the cartridge.Dfu (directions for use) states to completely fill the viewing window of the pcb00 with ovd (ophthalmic viscosurgical device).The intraocular lens was not returned.There were indications of coating at the cartridge canopy.Some stretch marks were observed on the cartridge that could be related to the delivery of the lens.No molding defect was observed on the cartridge; the cartridge is not deformed/ bent.The customer's reported complaint was not verified.A product quality 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 no additional investigation request for this production order number has been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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.
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.

• 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: 8365054
• Report Number: 2648035-2019-00226
• Device Sequence Number: 19335363
• Product Code: HQL
• UDI-Device Identifier: 05050474558212
• UDI-Public: (01)05050474558212(17)211020
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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): 11/09/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 03/25/2019; 10/25/2020
• Initial Report FDA Received Date: 02/24/2019
• Supplement Report FDA Received Date: 04/18/2019; 11/10/2020
• 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: 66 YR
• Date Report Sent to FDA: 01/01/2005