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

Model Number	PCB00
Medical Device Problem Codes	Contamination (1120); Scratched Material (3020)
Health Effect - Clinical Codes	Corneal Edema (1791); No Code Available (3191)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).If implanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.(b)(6).All pertinent information available to (b)(6) has been submitted.
Event or Problem Description
It was reported that the implantation of the intraocular lens (model pcb00) into the left eye (os) of the patient, went well.Reportedly, when the lens was in the eye, the doctor discovered a stain / scratch on the center of the optic and decided to remove the lens and replace it with a new pcb00, same diopter size.The incision had to be enlarged to remove the lens and the procedure was delayed by about 20 minutes.No vitrectomy was required and no further procedures were performed or planned.One day post-op, remaining edema was observed in the incision-area.Refraction: -2,25 -1,25 131, visual acuity 0.63.No additional information was provided.
Additional Manufacturer Narrative
Date received by manufacturer: 3/19/2019.Device evaluated by manufacturer.Device evaluation: the sample was received and visually inspected using magnification.The lens from the preloaded insertion system was returned cut (from the lens edge across the optic) making it visually impossible to observe unacceptable scratches if any on the return.Dried residues of viscoelastic were observed adhering on the optic body of the lens and haptics, making it visually impossible to detect any stain on the lens.The condition observed is consistent with a lens that has been cut due to removal procedure.No lens damages or cosmetic defects due to manufacturing error could be observed.The reported issue could not be confirmed.Based on the product returned evaluation a product quality deficiency or product malfunction could not be determined.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed no additional complaints were received for this production order.Labeling review: the directions for use (dfu) were reviewed.The directions for use (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: 8447487
• Report Number: 2648035-2019-00378
• Device Sequence Number: 2926480
• Product Code: HQL
• UDI-Device Identifier: 05050474558199
• UDI-Public: (01)05050474558199(17)210802
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 11/10/2020
• 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: 08/02/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 04/04/2019; 10/25/2020
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 05/02/2019; 11/11/2020
• 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
• Date Report Sent to FDA: 01/01/2005