MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	ZCT225
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Zonular Dehiscence (2698); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event: unknown, not provided.Best estimate of date of event is before nov 30, 2023.Section h3-other (81): the device was not returned for evaluation and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the serial number was not provided.Section h6: health effect impact code: 4625 ( to capture unplanned vitrectomy).Section h6: health effect clinical code; 4581 ( to capture device decentered or dislocated or tilted subluxated or wrong position).Attempts have been made to obtain missing information; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Report of tecnis toric intraocular lens (iol) dislocation in a patient's left eye, with planned repositioning or explant was received.Successful exchange took place which the surgeon performed a new modified yamane style technique with nylon sutures for scleral fixation of a zcu225 16.5d iol to replace the dislocated zct225 16.0 iol.It was confirmed that the dislocation was due to zonular dehiscence and that an anterior vitrectomy was necessary.No other information was provided.
Additional Manufacturer Narrative
Additional information: new information received that suspect lens serial number is (b)(6) and that the removed lens was not saved.Per implant card in system then found to have patient initials of (b)(6), date of birth (b)(6)1951, implant date (b)(6)2018.Implant doctor dr.(b)(6), expiration date: (b)(6) 2018, udi number (b)(4), device manufacture date is (b)(6)2014.Also, per system the rga# was received but no product was returned.Fields below updated.Section a2: date of birth: (b)(6)1951.Section d4: serial number (b)(6).Section d4: expiration date: nov 27, 2018.Section d4: udi number: (b)(4).Section d6a: implant date: (b)(6)2018.Section h4: device manufacture date: nov 27, 2014.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18298393
• Report Number: 3012236936-2023-03076
• Device Sequence Number: 12533052
• Product Code: MJP
• UDI-Device Identifier: 05050474552654
• UDI-Public: (01)05050474552654(17)181127
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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: 11/27/2018
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT2250160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 12/10/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: White