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

Model Number	PCB00
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; if explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.(b)(6).(b)(4).Device evaluation: product testing could not be performed since the product was not returned for evaluation.According to the initial report the lens is not available for investigation because it was discarded.Therefore, the reported issue could not be verified, and 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 on complaints revealed that one additional complaint was received from this production order for an unrelated issue that was not confirmed.Conclusion: the reported issue could not be verified, and product quality deficiency could not be determined.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during implantation of a model pcb00 intraocular lens, the haptic was noticed missing in the eye.The lens was removed and replaced it with a new lens.As per follow-up, an incision enlargement and sutures were required.The damaged lens is noted to have been discarded.No additional information provided.
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: 8978587
• Report Number: 2648035-2019-00978
• Device Sequence Number: 11594028
• Product Code: HQL
• UDI-Device Identifier: 05050474558205
• UDI-Public: (01)05050474558205(17)210909
• 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: Nurse
• Type of Report: Initial,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: 09/09/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000170
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 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
• Date Report Sent to FDA: 01/01/2005