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

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).It was indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt has 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 during intraocular lens injection, it was found that the intraocular lens haptic was broken and could not be implanted.A new intraocular lens was used and the surgery was uneventful.Product not available for return.It is unclear if issue occurred with patient contact or not.No further information available.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes date returned to manufacturer: 09 sept 2021 section h3: device returned to manufacturer: yes device evaluation: visual inspection under magnification revealed an uncoated cartridge with a stuck iol inside.There is viscoelastic residue inside the cartridge.The lens was removed from the cartridge, but the iol became torn and a haptic detached in the process.The lens was cleaned and a damaged haptic (bent) was also observed.The complaint issue was confirmed; however, based on the return condition of the lens, no further product evaluation could be performed and it cannot be confirmed to be related to a manufacturing issue.Therefore, no product deficiency could be identified.Manufacturing record review: based on the manufacturing records review, and historical complaint review, there is no indication of a product malfunction or product quality deficiency.No nonconformity report, documentation or labeling changes, and escalations are required.The search revealed that no other complaints have been received for this production order.Conclusion: based on the information obtained, product malfunction and product deficiency cannot be confirmed.No further investigation is required all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR 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: 12133286
• Report Number: 2648035-2021-08116
• Device Sequence Number: 11912351
• Product Code: HQL
• UDI-Device Identifier: 05050474502208
• UDI-Public: (01)05050474502208(17)241226
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/26/2024
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR