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

Model Number PCB00

Device Problems Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown, not provided.If implanted, give date: unknown/not provided.If explanted, give date: unknown/not provided.(b)(4).Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) was explanted.No other information was provided.

Manufacturer Narrative

Corrected data: correction is needed as initially it was reported that suspect lens was explanted.But further follow-up confirmed that suspect lens was removed and not explanted in a secondary surgical intervention.The patient code in section h6: patient code: 3191 in the initial report for explant, then no longer applies, as well as sections d6 and d7 do not apply as the lens was inserted and removed during the same procedure.Additional information: a duplicate report was received and new information was presented.Therefore, the following sections updated.Section a2: age/date of birth: 8/10/1953.Section a3: gender: female.Section b3: date of event: (b)(6) 2020.Section e1: name: dr.Claudio contreras.Additional information of lens being removed and doctor claimed that he pushed the plunger causing forceful ejection of the lens that resulted in dehiscence of the capsular bag.Doctor cut and removed the lens from the patient¿s right eye and patient left aphakic.Patient was referred to a retina specialist for fixation of a posterior chamber intraocular lens.The patient¿s reported visual acuity by retina surgeon is 20/40, but she has not had final refraction.The device was not returned.H6: patient code: 3191: zonular dehiscence; incomplete treatment, unspecified; removal; secondary surgical intervention.Device evaluation: since product was not returned, the complaint issue reported could not be verified.Product deficiency could not be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed one additional complaint folder for this production order number ¿dc-device advancement issue¿.Product deficiency not identified.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10849552
• MDR Text Key: 216705252
• Report Number: 2648035-2020-00858
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558304
• UDI-Public: (01)05050474558304(17)221029
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000220
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR