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

Model Number	ZCB00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unknown, information not provided.The device was not returned for analysis as the lens 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.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zcb00 model intraocular lens(iol) was explanted from patient's left eye due to lens getting dislocated.Also ppv and limbal relaxation incisions were done at the time of explant.Patient was referred on day 1 post op for a dislocated iol through the posterior capsule during surgery and doctor's report states that anterior capsule appears to be intact, lens dislocated behind the posterior capsule in anterior vitreous, posterior capsule was disrupted.Additional details received states that dislocation happened at the time of surgery.There was no patient injury.Incision was not enlarged to remove the lens from patient's eye and also no sutures were done.The replacement lens used is a different model (za9003), za9003 same diopter lens.Patient outcome was good and no patient injury was reported.Suspect product has been discarded.No further information available.
Additional Manufacturer Narrative
Device evaluation: no complaint product was returned for evaluation.A customer provided photo was received for evaluation which was forwarded to the rapid response team (rrt) for further evaluation.Per subject matter expert (sme) from the rrt, the photo evaluation is as follows.The 2 provided pictures show slit lamp pictures taken using retroilumination and dark field technique pseudophackic eye showing an intraocular lens luxated downwards, like sun set syndrome and a posterior capsule integrity compromised starting right at the superior edge of the iol optical portion, although it is possible that the iol luxation was triggered by the posterior capsule rupture, it can not be confirmed from the picture assessment.No issues with the device were observed, the observed phenomenon in the customer provided photo is related to patient/anatomical issues.The complaint issue could not be confirmed and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed no additional complaints from this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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
• MDR Report Key: 12369150
• Report Number: 2020664-2021-07155
• Device Sequence Number: 11779063
• Product Code: HQL
• UDI-Device Identifier: 05050474531710
• UDI-Public: (01)05050474531710(17)240831
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 08/31/2024
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/19/2021
• 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