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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter name: reporters full first name is unknown and only the first letter of the first name "r" is available.Device evaluated by mfr: other (81): the device was not returned for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was implanted and explanted.The reason for the explant was not specified.No medical or other surgical interventions were indicated.It was indicated the product will not be returned.The patient outcome was not provided.No further information is available.
Additional Manufacturer Narrative
Additional information/corrected data: in the initial mdr report, it was inadvertetly indicated that the lens was implanted and explanted due to unspecified reason and codes "health effect - impact code - 4629" and "health effect - clinical code - 1845" were used which the information was incorrect as based on the additional information received from the customer the lens fully inserted, then removed and replaced on the same day, during the same procedure.The date of implant/explant/date of surgery was reported to be (b)(6) 2022.It was indicated that there was a capsule tear which a vitrectomy was required, incision was enlarged and suture was used.It was confirmed that the device was discarded.The patient was a male with date of birth of (b)(6) 1964.The following fields were updated accordingly based on the new received information: section a2: date of birth: (b)(6) 1964, section a3: gender: male, section b3: date of event: dec 28, 2022, section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section e1: reporter's title, fist & last name: dr.(b)(6).Section e2: health professional?: yes.Section e3: occupation: physician.Section h6: health effect - impact code: 4625 - vitrectomy, incision enlargement & suture.Section h6: health effect - impact code: 4631, section h6: health effect - clinical code: 2639, section h6: health effect - clinical code: 4581- incision enlargement.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received from the customer indicated that the patient had preexisting anterior capsule defect that extended when the lens was implanted.The posterior capsule tore once the lens was implanted and was falling back to the posterior segment so had to retrieve it, explant it, and place an anterior chamber (ac) intraocular lens (iol).It was indicated that the patient had pre-existing medical history of proliferative diabetic retinopathy with vitreous hemorrhage.The patient outcome was reported that the patient is getting diabetic treatment for vitreous hemorrhage but otherwise doing well.Vision set for near and is seeing 20/400 and pinhole 20/70 last visit.But likely will correct after vitreous hemorrhage improved.No further information was provided.The following field was updated accordingly: section b7: other relevant history, including preexisting medical conditions (e.G allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.): proliferative diabetic retinopathy with vitreous hemorrhage.Corrected data: upon further review of the event and based on the new information received from the customer, since the patient already had an anterior capsule tear/defect that extended posteriorly, there is no allegation that the lens caused the reported capsule tear requiring surgical interventions.Therefore, the event is no longer reportable and no further information will be provided under this manufacturer report number 3012236936-2023-00189.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 16260470
• Report Number: 3012236936-2023-00189
• Device Sequence Number: 17398340
• Product Code: HQL
• UDI-Device Identifier: 05050474531697
• UDI-Public: (01)05050474531697(17)261102
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000190
• 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: 01/05/2023
• Supplement Date Received by Manufacturer: 01/26/2023; 03/10/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/01/2023; 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• 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: Male